test

The Authority

The Authority

The Authority

Flow Forward Closes $1.3 Million of Additional Series A Financing

Human Health published Tue, 2015-05-26 10:53

 OLATHE, Kan. - May 18, 2015 - Flow Forward Medical Inc. (Flow Forward), an early-stage company focused on improving outcomes for hemodialysis patients through the rapid creation of high-quality vascular access sites, today announced that it has closed a $1.3 million round of additional Series A financing, led by existing investor, the Kansas Bioscience Authority (KBA). Flow Forward previously raised $4.4 million in Series A funding, bringing the total in equity funding raised to date to approximately $5.7 million. Series A proceeds will be used to continue the development of Flow Forward's Arteriovenous Fistula Eligibility (AFE) System™, a small, minimally invasive blood pump system designed for temporary use to rapidly dilate peripheral veins through flow-mediated vascular remodeling prior to arteriovenous fistula (AVF) surgery.

 

Flow Forward also announced today that it will receive a $225,000 Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The SBIR funding will be used to test peripheral vein dilation with the AFE System prior to AVF creation in a nonclinical model.

 

"Many of the two million patients on hemodialysis worldwide who undergo conventional surgical AVF creation each year experience vascular access site failure, which is associated with increased morbidity. With its AFE System, Flow Forward is addressing issues known to contribute to AVF failure," said Tom Krol, Managing Director at KBA and a member of Flow Forward's board of directors. "In early studies conducted in a challenging nonclinical model, the company has shown much more rapid vein dilation, large increases in blood flow and a significant reduction in vein wall scarring, when compared with conventional AVF creation. We believe that the AFE System has the potential to drive broad increases in AVF eligibility as well as large reductions in AVF failure."

 

Flow Forward also announced today the appointment of Kurt Dasse, PhD, to its board of directors. Dasse has spent nearly three decades conducting cardiovascular research and developing products to treat heart, lung and kidney diseases. He is currently President and CEO of GeNO LLC, a biopharmaceutical company developing next-generation delivery systems for inhaled nitric oxide, a pharmacologic blood vessel dilator. He was previously President and CEO of Levitronix LLC, a developer and manufacturer of rotary blood pump systems for cardiopulmonary support that was acquired by Thoratec Corporation in 2011.

 

"I am pleased to have additional financial resources from KBA and the NIH's SBIR program to accelerate the development of the AFE System. I also welcome Kurt to our Board. His decades of industry experience and deep domain experience in cardiovascular biology and physiology will be invaluable as we work to realize our goal of providing physicians more and better options when creating vascular access sites for hemodialysis patients," said F. Nicholas Franano, MD, President and CEO of Flow Forward.

 

 

 

 

 

 

 

 

Share

Traverse Biosciences Executes Agreement with Aratana for Periodontal Disease in Dogs and Cats

Animal Health published Wed, 2015-05-06 09:26

Stony Brook, NY; May 4, 2015: Traverse Biosciences announced today that it has executed a $250,000 cooperative research and development agreement (CRADA) with Kansas-based Aratana Therapeutics Inc. (NASDAQ:PETX) to advance the development of TRB-N0224 for the treatment and control of periodontal disease in companion animals, including dogs and cats. 

The funds provided by Aratana under the CRADA will be used by Traverse Biosciences primarily to conduct a proof-of-concept (POC) efficacy study to evaluate TRB-N0224, a proprietary chemically-modified curcumin, in an accepted animal model of canine periodontal disease. Canine periodontal disease affects approximately 80% of dogs by age three, with the highest incidence in smaller breeds and older animals. Periodontal disease in dogs, of which there are approximately 83 million pets in the U.S. alone, leads to serious oral health complications, and can impair liver, kidney, cardiac and metabolic function. Traverse Biosciences also intends to conduct pilot pharmacokinetic, pre-formulation and preliminary safety studies during the term of the agreement.

Mr. Joseph Scaduto, Founder and CEO of Traverse Biosciences, stated, “The global animal health market is rapidly expanding, and this growth represents a significant business opportunity for companies developing innovative products that address unmet needs in veterinary medicine. We are very fortunate and excited to engage with Aratana Therapeutics to accelerate the commercialization of TRB-N0224 for the treatment and control of periodontal disease in companion animals.”

Dr. Steven St. Peter, Founder, President and CEO of Aratana Therapeutics, commented, “We are pleased to initiate this strategic partnership with Traverse Biosciences given the opportunity that TRB-N0224 represents as a potential therapeutic for periodontal disease in dogs and cats.  Aratana is committed to providing veterinarians with new therapies that are deeply rooted in science, and which are specifically made for pets.  Our pipeline currently consists of more than 18 therapies to treat a variety of diseases affecting companion animals. TRB-N0224 would be the first product to treat an oral health condition.”

 

Read the full announcement here.

 

Share

AAD announces three new board members

Animal Health published Thu, 2015-03-26 16:30

Advanced Animal Diagnostics (AAD) has recently added three individuals to its board of directors, following the recent close of its $15 million Series C round of equity financing. Bob Shapiro, managing director of Cultivian Sandbox Ventures; Tony Simpson, managing director of Kansas Bioscience Authority; and Dennis Dougherty, managing general partner of Intersouth Partners joined the board of directors to guide AAD, a developer of rapid on-farm diagnostic technologies.  

 

AAD provides diagnostics that detect disease early and accurately, empowering livestock producers to make real-time management decisions that increase productivity, prevent losses, improve animal welfare and protect the food supply. AAD developed and launched QScout® MLD (milk leukocyte differential) test for early detection of subclinical mastitis in dairy cows, along with QScout® Farm Lab which reads QScout MLD and other rapid, on-farm tests in development.

 

“We are fortunate to augment our board with these visionary leaders,” says AAD CEO Joy Parr Drach. “Each brings distinct and deep experience in developing innovative agricultural and life sciences companies.”

 

Shapiro, whose Illinois-based Cultivian Sandbox Ventures invests in emerging technologies that address agriculture’s biggest challenges, says AAD fits well into their mission as investors as it offers advanced technologies that help livestock producers manage their animals better and run more efficiently as a business.

 

“What’s most important about AAD technology is it provides early diagnosis of disease, and therefore better prospects for treatment,” continues Shapiro, former Monsanto CEO. “As with human diagnostics, we want early indications so we can treat diseases more efficiently and minimize their damage. Applying these advanced technologies to the health of animals raised to provide nutrition to humans is of great importance to livestock producers in this country and around the word, and to all of us as consumers.”

 

Shapiro is the co-founder and managing director of Sandbox Industries, a venture capital firm that partners with Cultivian Sandbox for investments in food and agriculture technology. He is the former chairman of Pharmacia, chairman and CEO of Monsanto, and chairman and CEO of The NutraSweet Company. He previously served as vice president and general counsel of G.D. Searle & Company and General Instrument Corporation. Prior to this, he practiced law in New York City and was a professor of law at Northeastern University in Boston and the University of Wisconsin-Madison. He is a Fellow of the American Academy of Arts and Sciences.

 

Simpson spent nine years with POET, where he started two major green-field ethanol plants and led equity drives, refinancings and expansion efforts for these facilities. Before that, he held positions at ADM in trading and plant operations management. He also served as general manager for ED&F Man’s ethanol operations in the United States, leading asset management and business development efforts. Simpson serves on the selection committee for the Animal Health Investment Forum, chairs the selection committee for the ag, food and bioenergy tract for InvestMidwest Venture Capital Forum, and is a member of Global AgTech Investors Network.

 

Dougherty founded Intersouth Partners in 1985 and led investments in ag companies like Athenix and Paradigm Genetics. Previously, Dougherty was an office managing partner and head of the high growth business practice for Touche Ross & Co. Dougherty is active in the venture industry, having served on the National Venture Capital Association board of directors and Kauffman Fellows Program steering committee. He was a mentor for two classes of Kauffman Fellows, and served on the North Carolina State University Seed Fund board and Governor’s Biotechnology Steering Committee. He was a founder of the Council for Entrepreneurial Development and chair of its first Venture Conference.
 

They join AAD board members Steve Weinstein, managing director of the Novartis Venture Fund; Ben Shelton, DVM, owner of Rocky Creek Dairy and Rocky Creek Veterinary Service; Joy Parr Drach, AAD president and CEO; and chairman of the board Randall Marcuson.   
 

About Advanced Animal Diagnostics

Advanced Animal Diagnostics (AAD), Durham, N.C., provides livestock producers with diagnostics that improve profitability and empower more precise care of animals so they live healthier, more productive lives. AAD is committed to researching, developing and commercializing the industry’s most reliable, on-farm diagnostic tests, such as QScout MLD test for early detection of subclinical mastitis in dairy cows. With its diagnostic offerings, the company aims to empower real-time management decisions that increase productivity, prevent losses, improve animal welfare and protect the food supply. For more information, visit www.QScoutLab.com.

 

Share

Metactive Closes $2 Million of Additional Series A Financing

Human Health published Mon, 2015-02-23 15:57

OLATHE, Kan. - Feb. 23, 2015 - Metactive Medical Inc. (Metactive), an early-stage company focused on developing embolization devices for the treatment of peripheral vascular and neurovascular diseases, today announced that it has closed on $2 million of additional Series A financing, led by the Kansas Bioscience Authority (KBA), an existing Metactive investor. Proceeds will be used to continue the development of Metactive's novel embolic devices for occlusion of saccular aneurysms and peripheral arteries and veins. Metactive previously raised $5 million in Series A funding, bringing the total funding raised to date to $7 million.
 

"Metactive has shown immediate, complete and lasting occlusion of large saccular aneurysms with rapid endothelialization of the aneurysm neck in a challenging nonclinical model, as well as similarly robust performance with a peripheral occlusion device," said Tom Krol, Managing Director at KBA and a member of Metactive's board of directors. "Clinicians treat thousands of saccular aneurysms and peripheral arteries and veins each year. We believe that Metactive's devices have the potential to be better for patients, faster and easier for physicians to use, and less expensive for payers."

 

Metactive also announced today the appointment of David Ferrera to its board of directors. Ferrera is currently President and Chief Technology Officer of Blockade Medical and has 20 years of leadership experience in the medical device industry at several market-leading neurovascular firms, including MindFrame, Microvention and Micrus Endovascular.

 

"I am pleased to have the resources to accelerate the development of our novel, potentially life-saving products and to welcome David to our board to help us realize our goal of providing physicians faster, better and less expensive options for vascular occlusion," said F. Nicholas Franano, MD, President and CEO of Metactive.

 

About Peripheral Artery and Aneurysm Embolization

Embolization is a minimally invasive treatment that blocks the flow of blood in selected segments of arteries and veins, enabling physicians to divert blood away from cancerous tumors and other abnormal tissues, as well as from damaged or malformed segments of blood vessels. More than 150,000 peripheral vascular embolization procedures are performed each year worldwide using coils and vascular plugs. Similarly, more than 150,000 cerebral aneurysm embolization procedures are performed worldwide each year using coils and flow-diverting vascular stents. There is currently a need in these markets for endovascular embolization devices that can be placed quickly and easily, with a high degree of precision, and that result in immediate and lasting occlusion.

 

About Metactive Medical

Metactive is developing novel endovascular medical devices for the treatment of neurovascular and peripheral vascular diseases. Metactive's first products enable precise and immediate occlusion and rapid sealing of cerebral aneurysms and other target vessel segments using an over-the-wire microcatheter platform. For more information, please visit www.metactivemedical.com.

Share

Kansas Bioscience Authority to dramatically increase available funds

General published Mon, 2015-02-23 17:31

By Alyssa Scott, KU Statehouse Wire Service

TOPEKA — The Kansas Bioscience Authority (KBA), a venture capital fund covering animal, human and plant health, intends to further invest in the Kansas bioscience sector in 2015 by quadrupling its available funds.

KBA CEO and Chairman Duane Cantrell told the Senate Commerce Committee on Wednesday that the KBA intends to make $420 million available for corporate investment, which is four times more than between 2009-14. He said KBA is able to quadruple its investment after restructuring.

“We’ve established two investment structures, and for every dollar we put into those structures, we expect two to four other dollars to come in from outside of Kansas,” he said. “In other words, when we put an investment in a company, we expect to get it back with the returns so we can do that again and again, and that’s how we’ve become sustainable.”

To become more effective, the KBA switched to a market-based, self-sustaining financial model two years ago.

“The money is now beginning to come back into the KBA,” Cantrell said. “Prior to two years ago, not a single dime ever walked back in the door of the KBA. In the last two years, $19 million has come back in, $17.7 million of that just last year.”

Sen. Jeff Melcher (R-Leawood) said he is pleased with the changes the KBA has made in how it invests.

“I was a harsh critic of us just giving away money and not expecting anything in return,” Melcher said. “On the other side of the coin, KBA 2.0, I’m fully supportive of it, and I would like us to fully fund it. It’s one of the few things that we fund in government that actually returns something to us that’s greater than what we put into it, and because of that I support it.”

The KBA has five key objectives that are expected to work with the new investment structures to help reach its goal of increasing available capital for the next five years. These include improving the return of investment, investment in opportunities, attracting private equity dollars to Kansas, increasing job availability, and increasing the export of products and services to a global market.

Cantrell said the bioscience sector is a key area of improvement because not only does bioscience work to solve global issues, such as food supply and safety, but it also benefits communities by providing high-quality and high-paying jobs. In addition, it is a relevant field in terms of Kansas’ strengths and resources.

“Basically one third of the global GDP, a $20 billion industry, of animal health is represented in the ‘corridor’ between Columbia, Missouri, to Manhattan, Kansas,” Cantrell said. “There is no other place in the United States, there is no other place in the world, that has that kind of concentration of animal health. Collectively, Kansas is well-positioned, and quite frankly about as well-positioned as any other state in the United States.”

http://www.hayspost.com/2015/01/29/kansas-bioscience-authority-to-dramatically-increase-available-funds/

- Alyssa Scott is a University of Kansas junior from Wichita majoring in journalism and French.

Share

Advanced Animal Diagnostics Closes $15 Million in Oversubscribed Series C Funding

Animal Health published Mon, 2015-02-23 17:46

DURHAM, NC — December 8, 2014 — Advanced Animal Diagnostics (AAD) announced today the close of a $15 million Series C round of equity financing. The financing was co-led by the Kansas Bioscience Authority and CultivianSandbox and included Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH), Middleland Capital, and existing investors Intersouth Partners, Novartis Venture Funds and private individuals. The investment will allow AAD to accelerate the commercialization of its current product offering, QScout® MLD (milk leukocyte differential) test, while also expanding the company’s product line.

AAD develops on-farm diagnostic technologies that change the way livestock producers manage animal health and costly diseases. The company launched its first commercial products, QScout MLD test and QScout Farm Lab, in 2013 to detect subclinical mastitis in dairy cows. Large-scale trials on commercial dairies demonstrated that the technology significantly improves producers’ financial returns by preventing milk and reproductive losses, safeguarding animal health through earlier detection and promoting more judicious use of antibiotics. 

“Investors and our growing number of customers see value in rapid, on-farm diagnostic information that hasn’t existed before,” said Joy Parr Drach, AAD president and CEO. “This new information allows producers to make more accurate management decisions to improve animal health and their bottom line while ensuring they use antibiotics only when needed to provide the best quality product for consumers.”

AAD customer John Freund of Son-Bow Farms in Wisconsin said QScout MLD is a significant improvement over conventional tests. “QScout MLD gives us a better, consistent approach for diagnosing subclinical mastitis, and it is more efficient for our labor flow compared to on-farm culture tests. The test’s objective results create a tremendous opportunity to address an issue, improve the quality of milk going into the tank, and provide a better product for consumers.”

The company expects to advance the development of additional livestock tests for dairy and beef markets, invest in production and manufacturing, and expand commercial efforts for new and existing customers with this financing.

About Advanced Animal Diagnostics
Advanced Animal Diagnostics (AAD), Durham, N.C., provides livestock producers with diagnostics that improve profitability and empower more precise care of animals so they live healthier, more productive lives. AAD is committed to researching, developing and commercializing the industry’s most reliable, on-farm diagnostic tests, such as QScout MLD for early detection of subclinical mastitis in dairy cows. With its diagnostic offerings, the company aims to empower real-time management decisions that increase productivity, prevent losses, improve animal welfare and protect the food supply. For more information, visit www.QScoutLab.com or call 1-855 Q2COUNT.

About the Investors:

Kansas Bioscience Authority
Kansas Bioscience Authority is a venture investor focused in agribusiness, animal health, and human health innovations. The team brings deep sector expertise and co-investors together to accelerate bioscience company growth generating results for the entrepreneur, the investor, Kansas and the world. For more information, please visit www.kansasbioauthority.org.

Cultivian Sandbox
Cultivian Sandbox is a venture capital fund focused on high-technology opportunities in the food and agricultural sectors. Cultivian Sandbox operates from the Midwest, which hosts the world’s greatest concentration of public and private R&D spending for food and agricultural markets. Cultivian Sandbox works closely with the management of emerging technology companies to bring cutting-edge technology solutions to market. The fund focuses on investments in the following areas: animal health, biobased products and processes, environmental technologies, food safety, human wellness, and production technologies. For more information, please visit www.cultiviansbx.com. 

LabCorp
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH), an S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $5.8 billion in 2013, over 34,000 employees worldwide, and more than 220,000 clients, LabCorp offers more than 4,000 tests ranging from routine blood analyses to reproductive genetics to companion diagnostics. LabCorp furthers its scientific expertise and innovative clinical testing technology through its LabCorp Specialty Testing Group:  The Center for Molecular Biology and Pathology, National Genetics Institute, ViroMed Laboratories, Inc, The Center for Esoteric Testing, Litholink Corporation, Integrated Genetics, Integrated Oncology, Dianon Pathology, Monogram Biosciences, Inc, Colorado Coagulation, Cellmark Forensics, MedTox, and Endocrine Sciences.  LabCorp conducts clinical trials testing through its LabCorp Clinical Trials division. LabCorp clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies. For more information, please visit www.labcorp.com.

Middleland Capital
Middleland Capital is a private investment firm focused on global early-stage technology  opportunities. Leveraging a unique breadth of geographic and industry experience, the firm seeks partnerships with exceptional management teams to commercialize innovative technologies, accelerate growth and build long-term value around the world. For more information, please visit www.middlelandcap.com.

Intersouth Partners 
Intersouth Partners is one of the most active and experienced venture capital firms in the Southeast, having invested in more than 100 private companies. Founded in 1985, Intersouth manages $780 million in seven venture capital limited partnerships, making it the largest venture capital fund in North Carolina and one of the largest in the Southeast. For more information, please visit www.intersouth.com.

Novartis Venture Funds
Established in 1996, the Novartis Venture Fund currently manages over $800 million in committed capital and is invested globally in more than 55 private life sciences companies across biotech, medical devices and diagnostics. As a financially driven corporate life science investor, the Novartis Venture Fund invests in those companies which have the potential to change a core therapeutic field or explore new business areas that will be critical to the patient.  For more information, please visit www.venturefund.novartis.com.

Share

Aratana licenses treatment for dogs with atopic dermatitis

Animal Health published Mon, 2015-02-23 17:50

Aratana Therapeutics Inc. has finalized a global licensing agreement with Ukraine-based Atopix Therapeutics Ltd. to develop and commercialize a drug for dogs to treat atopic dermatitis, also known as eczema.

Atopix is continuing to study the drug's use in humans to treat moderate to severe atopic dermatitis and is currently in a Phase 2 study of its drug, OC459.

"We believe this product fits nicely into our portfolio of companion animal therapeutics," Aratana CEO Steven St. Peter said in a release. "We continue to be committed to developing products that target the underlying cause of the disease rather than just the symptoms."

The Kansas City, Kan., animal health company (Nasdaq: PETX) paid $1 million to Atopix for the rights to all non-human health applications. Atopix will receive additional payments, such as royalties, as Aratana reaches "regulatory milestones."

- Leslie Collins,  Kansas City Business Journal

 

Share

InvestMidwest starts application process for entrepreneurs

General published Mon, 2015-02-23 17:53

The InvestMidwest Venture Capital Forum is accepting applications from entrepreneurs with high-growth companies hoping to raise capital from investors. The KBA is a co-sponsor of this annual event.

The event is April 1-2, 2015, at  the Sheraton Kansas City at Crown Center and typically attracts about 300 attendees and 45 presenting companies. It's a showcase for the best new high-growth businesses in the Midwest seeking growth capital. Presentations last about 10 minutes each.

Companies presenting at the previous 15 events raised more than $1 billion.

"We are seeking applications from throughout the Midwest from high-growth companies in search of substantial investment to punch their growth to a new level," Executive Director Christine Walsh said in a release. "We're not talking slow, organic growth. We're looking for fast-track companies."

The early application deadline ends Nov. 14. The late deadline is Jan. 16. Companies applying early are given deeper consideration by the selection committee, which will have more time to ask questions and seek clarification. Click the logo below for more information.

 

Share

Biova LLC announces new, second location in Kansas Bioscience Park

Human Health published Wed, 2014-09-24 10:57

Johnston, Iowa, USA—Biova LLC, the world leader for water soluble egg membrane ingredients, has expanded their cutting-edge technology into a new neighborhood.

The new Biova office at 10900 S.Clay Blair Blvd in Olathe, Kans., is located in the Venture Accelerator at the Kansas Bioscience Park, next to some of the leading—and fastest growing—science and technology businesses in the United States.

“Our expansion is so much more than elbow room,” said Matt Stegenga, Biova’s director of marketing. “There are great things happening at Biova. We wanted a scientific, collaborative community that understands the needs of growing technology companies. Kansas Bioscience Park checked all our boxes.”

The new Biova Olathe office will focus on managing the burgeoning product development and marketing operations for Biova’s egg membrane technologies and branded ingredients. Kathy Hockla, project manager, has been hired joining Stegenga in Biova's new Olathe offices.

About Biova:
Privately held and globally distributed, Biova is the market leader for water soluble egg membrane ingredients offering proven health benefits: BiovaFlex for joint health; BiovaDerm for skin care; and BiovaPlex® for animal health. Biova's patented water soluble process creates expanded delivery options for consumer products, including functional foods, beverages,lotions and more. Years of dedicated investment, ongoing scientific research and leading-edge technology are at the core of
these all-natural, ultra-pure, nutrient-rich ingredients. A focus on sustainable production, anchored by vertical integration with the largest U.S. egg producing and processing partners, assures Biova an almost unlimited supply of 100% U.S. domestic sourced raw material.

Share

Aratana seeks more than $40M in latest public stock offering

Animal Health published Thu, 2014-09-18 09:59

Aratana Therapeutics Inc. announced Wednesday it will offer 4.5 million shares of its common stock at $9.25 a share, which would raise about $41.6 million.

The Kansas City, Kan., animal health company announced its third public stock offering Wednesday.

According to information filed with the Securities and Exchange Commission, Aratana (Nasdaq: PETX) plans to use a portion of the proceeds to expand its commercial infrastructure in anticipation of future product launches. It also may use the money to in-license or acquire additional technologies or businesses, and continue development of its current technologies.

Aratana has spent the last year actively acquiring new companies and technologies to build its pipeline of therapies for companion animals.

In October 2013 the company entered the canine cancer business with its acquisition of San Diego-based Vet Therapeutics Inc.

Shortly after, it announced it had purchased Belgium-based Okapi Sciences, which is developing a handful of clinical-stage therapeutics for treating viral diseases in companion animals.

Later in 2014, Aratana licensed the right to commercialize human cancer products owned by Advaxis Inc. for use in pets. It also licensed a stem cell therapy from Vet-Stem Inc. that it plans to develop to treat osteoarthritis in dogs.

Reported by:

- Brianne Pfannenstiel, Kansas City Business Journal

Share

CritiTech Names Mechanical Systems, Inc. As Its Exclusive Drug Manufacturing Equipment Supplier

General published Tue, 2014-08-26 14:17

LAWRENCE, KS – CritiTech, Inc. has named Mechanical Systems, Inc. (MSI) of Wichita, Kan., as its official and exclusive supplier of fine-particle drug manufacturing equipment.

As a long-time partner, MSI has been instrumental in helping CritiTech develop manufacturing equipment that produces commercial quantities of fine-particle drugs using CritiTech’s proprietary supercritical fluid carbon dioxide-based technologies.


MSI has decades of experience designing and constructing manufacturing equipment for the biotechnology and pharmaceutical industries, serving clients such as Boehringer-Ingelheim, Hospira, Bayer, Abbott, Pfizer, and Shering-Plough.


“This is an ideal match for both companies,” said Matthew McClorey, president of CritiTech. “CritiTech is in the business of enabling new and improved drugs with our technology, not constructing manufacturing equipment. Thus, the relationship with MSI allows us to focus on what we do best. We are extremely fortunate to have MSI as our exclusive equipment supplier. Its engineering experience and expertise is outstanding.”


MSI has already built, designed and installed equipment that CritiTech is currently using to provide fine-particle drug development services to its clients. The exclusive supplier agreement with MSI ensures CritiTech will have the commercial engineering expertise required to scale its technology and meet customers’ drug manufacturing demands.


Equipment from MSI will also be used to produce Nanotax®, a novel, fine-particle reformulation of paclitaxel to treat intraperitoneal cancers enabled by CritiTech’s technology. A Phase I Trial for Nanotax that produced positive results was recently completed.

“MSI is very excited about the partnership with CritiTech,” said Greg Johnson, president of MSI. “CritiTech’s technology is unique and very valuable, as evidenced by its ovarian cancer drug, Nanotax. Just as the technology was used to develop Nanotax, we believe it can be used to develop other drugs that are more effective, safer and better tolerated.”


About CritiTech, Inc.
CritiTech is a drug delivery and development company focused on using the company’s proprietary Supercritical Fluid Technology (SCF Technology) to help its clients and partners develop and manufacture unique and differentiated drugs and medical devices. CritiTech specializes in optimizing the delivery of challenging drug substances, potent molecules and poorly soluble compounds. By combining its SCF Technology with its ability to simplify formulations, CritiTech can expand and improve the drug delivery options for oral, injectable, and inhaled drugs, as well as implantable devices.


About Mechanical Systems, Inc.
MSI is a leading mechanical construction firm with support engineering and IT staff. The firm specializes in working with clients that service the biotechnology, pharmaceutical, and chemical fields. MSI has significant experience and expertise in designing, building, and installing equipment used to manufacture biologicals and chemicals. In addition to the mechanical design services provided, MSI also operates three biotechnology facilities in Wichita. These facilities produce a variety of biological products for agriculture and food additives. The agricultural products include bio-fungicides, plant growth promoting bacteria and nitrogen fixing bacteria. These facilities include clean production space, clean packaging suites and analytical laboratories.

Share

KC Animal Health Corridor Grows to Represent 56 Percent of Global Industry Sales

Animal Health published Tue, 2014-08-26 09:54

New survey reveals increased corporate presence in KC region

August 25, 2014The Kansas City Animal Health Corridor has released new evidence of the global impact of the KC region’s animal health industry concentration. Companies with a strategic location in the KC Animal Health Corridor now represent 56 percent of total worldwide animal health, diagnostics and pet food sales.

The new evidence results from a recent asset survey, unveiled to 850 animal health industry leaders attending tonight’s 9th Annual KC Animal Health Corridor Homecoming.

“This latest survey is a powerful endorsement of nearly a decade of cooperation, teamwork and strategic focus that has driven the activities of the KC Animal Health Corridor effort since 2006,” said Scott Bormann, Corridor Advisory Board chair and vice president of U.S. operations for Merck Animal Health.

Organic industry growth resulting from mergers/acquisitions and corporate expansions within the Corridor have contributed to the KC region’s growing industry concentration. In addition, strategic outreach by the Kansas City Area Development Council to recruit new animal health companies to the region continues to be successful.

“We are so proud of the regional partnership that exists among the economic development, civic, corporate, academic and governmental leadership in the KC Animal Health Corridor,” said Kimberly Young, vice president of bioscience development at the Kansas City Area Development Council. “We are widely recognized as the strongest and most admired team in the global animal health industry.”

Since the KC Animal Health Corridor launched in 2006, 31 animal health companies have located in the KC Animal Health Corridor. These companies have pledged to create 1,368 new jobs resulting in $78.6 million in new payroll. They have made a total $872.5 million capital investment, occupying 1,054,138 million sq. ft. of new space.

A stable base of animal health companies with a U.S. headquarters in the KC Animal Health Corridor has provided a strong foundation for new industry growth. Companies with a U.S. headquarters located within the Kansas City Animal Health Corridor now represent 29 percent of the worldwide sales of animal health products and diagnostics.

The 2014 KC Animal Health Corridor Asset Survey was conducted and analyzed by Axxiom Consulting.

About the KC Animal Health Corridor
The KC Animal Health Corridor, anchored by Manhattan, Kansas, and Columbia, Missouri, is home to more than 300 animal health companies, representing the largest concentration in the world. For more information, visit KCanimalhealth.com.

Share

FlexiLume Dental LED System Receives FDA Approval

Human Health published Mon, 2014-08-18 16:36

Mission, Kansas -  EMCI is proud to announce that the FlexiLume Dental LED System has received regulatory clearance for sale worldwide, including FDA approval and CE mark.


Peter Lucas, COO of EMCI, says, “The FlexiLume represents a paradigm shift in dental workflows that will improve doctor, hygienist, and patient experiences. We are very excited that we can now offer the product to dentists
worldwide, and we believe strongly that it will be very popular.”


“I believe that with this product we have achieved a whole new concept in operatory lighting systems. Access, visibility, and efficiency are very important procedural dependents for success within the operatory; the flexible extension arm delivers the light source directly where it is needed, and satisfies all of these elements. Placement of the light, curing tip, or transdental illumination on the tooth allows the clinician to achieve a “hands free” technique, and makes this system unbelievably easy to use. That alone, is worth the investment,” says Dr. Irwin Boe, inventor and founder of Innovative Products, Inc. Innovative Products, Inc., is a Kansas-based corporation with numerous inventions and patents, and dedicated to constant innovation in the field of dentistry.


James Lucas and Peter Lucas founded EMCI in 2006. Its focus is medical device innovation and development. The company has a solid history in the medical device industry and is currently developing and commercializing a wide array of new, cutting-edge technologies.  For more information: www.emci.co/flexilume.

 

Share

HEARTLAND PLANT INNOVATIONS HIRES NEW CHIEF SCIENTIST

Agribusiness published Tue, 2014-08-12 11:22

MANHATTAN, Kan. - Heartland Plant Innovations (HPI) has announced the hiring of Dr. Muhammad Asif as its new Chief Scientist.  Asif will be charged with leading HPI’s scientific efforts including novel trait development as well as the Advanced Plant Breeding Services.  HPI offers wheat doubled haploids, wide hybridization/trait introgression, and genotyping as services to customers world-wide.  All services are provided without claim to intellectual property which makes HPI attractive to wheat breeders working on advanced germplasm. 

Asif comes to HPI with over 10 years of experience in wheat improvement including doubled haploids – both maize and microspore method - marker assisted breeding, and variety development.  Asif most recently has served as a Postdoctoral Fellow at the Department of Agriculture, Food Nutritional Science, University of Alberta, Canada focusing on the development of genetic resistance from pyramiding rust (leaf, stem and stripe) resistance genes.  Asif’s graduate education was received at the University of Alberta, Edmonton, Canada where he co-developed a hard red spring wheat germplasm line (PT771) which exhibits Fusarium Head Blight resistance.  Asif has written extensively, including two books recently published by Springer, USA.  The books are titled “Progress and Opportunities of Doubled Haploid Production”, and “Managing and Breeding Wheat for Organic Systems: Enhancing Competitiveness Ability against Weeds.”    

HPI’s Interim President and Chief Financial Officer, Rob Berard, speaking in regard to Asif’s hiring said “I am very excited to have Asif join HPI.  It was obvious based on his experience in wheat improvement that his research focus aligned with HPI’s mission, however in getting to know him during the interview process it became clear that this his personality was also a fit.  It became a simple decision to hire Asif.  I can’t wait to get him thinking about the work of HPI on a full time basis.  Our customers will benefit greatly, I am confident.”

HPI provides customers with advanced plant breeding services and high-value genetic traits.  HPI’s breeding services include wheat doubled haploids, wide hybridization, and genotyping.   HPI has produced and sold over 40,000 doubled haploids to 21 Universities, 5 USDA labs, and 8 private companies in 5 countries.  In late 2013, HPI relocated into the state-of-the-art Kansas Wheat Innovation Center which provides HPI with the capacity to produce up to 50,000 doubled haploid lines per year as well as development of wheat traits.  As a research partner HPI is sponsoring multiple research programs at Kansas State University focused on wheat and sorghum.  These projects are seeking to increase the yields and end use performance of wheat, based on input from our industry partners. 

Share

Aratana Therapeutics Reports Second Quarter 2014 Results

Animal Health published Tue, 2014-08-12 14:39

KANSAS CITY, Kan., Aug. 12, 2014 /PRNewswire/ --  Aratana Therapeutics, Inc. PETX +7.07% , a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals, today announced its second quarter 2014 results.

"We continue to advance our highly innovative pipeline," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics.  "This quarter, we were very pleased that we were able to file our third product for licensure – a cancer vaccine to treat dogs with osteosarcoma."

Aratana's diversified portfolio now consists of more than fifteen therapeutic candidates: two have received conditional licensure, one has been submitted for licensure, more than ten are in active development and several additional candidates are in pre-development.

Development Highlights:

  • Aratana is currently enrolling dogs in two studies investigating the use of AT-005, the Company's conditionally licensed monoclonal antibody for treatment of T-cell lymphoma, in combination with chemotherapy. Aratana continues to anticipate making AT-005 available commercially to a limited number of clinics in the fall of 2014.  After receipt of a full license for AT-005 from the United States Department of Agriculture (USDA), which Aratana continues to expect in 2015, commercial availability will be further expanded.

  • Aratana continues to anticipate full licensure from the USDA of AT-004 in 2014, the Company's conditionally licensed monoclonal antibody for the treatment of B-cell lymphoma.  AT-004 is partnered in the US and Canada.

  • AT-001 (grapiprant, EP4 receptor antagonist for osteoarthritis pain): Aratana continues to enroll the pivotal field effectiveness study in client-owned dogs; Aratana continues to anticipate top-line results in 2014 and first U.S. Food and Drug Administration (FDA) approval in 2016.  Aratana initiated a pilot field study in client-owned cats in the second quarter.

  • AT-002 (capromorelin, ghrelin agonist for appetite stimulation): Aratana continues to enroll the pivotal field effectiveness trial in client-owned dogs; Aratana continues to anticipate top-line results in the first quarter of 2015 and first FDA approval in 2016.  Aratana initiated a pilot field study in client-owned cats in the second quarter.

  • Aratana filed for a product license from the USDA for AT-014, a novel cancer immunotherapy for the treatment of canine osteosarcoma. This product was licensed exclusively from Advaxis, Inc. in March 2014.

  • AT-003 (bupivacaine extended release injectable suspension for post-operative pain): Aratana is near completion of  a pilot study in client-owned dogs and will be discussing the design of the pivotal field effectiveness with the FDA in coming months; Aratana continues to anticipate the first FDA approval in 2016.  Aratana expects to start a cat pilot lab study in the fourth quarter 2014. 

  • During the quarter, the Company licensed commercial rights to a novel, allogeneic stem cell therapy technology (AT-016).  This FDA-regulated therapy is being developed to allow stem cells from a single donor to be processed to generate more than 1 million doses that can be stored and used to treat multiple dogs with osteoarthritis.  A multi-center, placebo-controlled, dose confirmation study was recently initiated by Aratana's partner, Vet-Stem, Inc.

  • AT-006, the Company's partnered antiviral for treatment of ocular lesions associated with feline ocular herpes infection, closed enrollment on a partially-enrolled pivotal field study in Germany to harmonize the program to enable a concurrent US and EU development plan.  The closed study will not enable a pivotal submission in 2015. 

  • During the quarter, one of Aratana's two products in the Option Programs, the AT-Beta option period was extended until mid-2015. If Aratana elects to move AT-Beta into development it will be developed for seizures in dogs.

  • During the quarter, Aratana completed a proof-of-concept study for its AT-Gamma option program.  Aratana has delivered notice of its intent to exercise a license agreement, and anticipates completing the agreement in 2014.  AT-Gamma is a CRTh2 antagonist, which will be developed for atopic dermatitis in dogs.

  • During the second quarter, the Company presented three peer- reviewed abstracts at the American College of Veterinarians Internal Medicine (ACVIM) meeting; Aratana will be presenting three additional abstracts at the Veterinary Cancer Society meeting in October.

  • For more information, please visit www.aratana.com.

Share

CritiTech and European Medical Contract Manufacturing Announce Collaboration

Human Health published Tue, 2014-08-05 09:34

LAWRENCE, KS – CritiTech, Inc., a growing drug delivery and development company, announced today that it has entered into a collaboration with European Medical Contract Manufacturing (EMCM) of Nijmegen, Netherlands, to develop tissue grafts coated with a variety of drugs using CritiTech’s proprietary supercritical fluid technology. The coated tissue grafts are being developed to provide effective and long-lasting antimicrobial control and rapid healing, especially in revision surgeries, to compensate for and correct failed implants.


“By combining EMCM’s eCOO® proprietary manufacturing process with CritiTech’s active pharmaceutical ingredients (API) coating technology, CritiTech and EMCM expect to produce tissue grafts that preserve their flexibility and maintain their structural and mechanical properties,” said Gary Clapp, CritiTech’s Vice President of Technical Operations. Coating EMCM’s tissue grafts with CritiTech’s supercritical fluid technology should produce unique benefits such as: (1) enabling the use of a wide range of APIs; (2) use of pure APIs; (3) delayed release of the APIs; and (4) incorporation of biodegradable release agents.


The goal of the collaboration between CritiTech and EMCM is to develop the first commercial tissue grafts coated with API using supercritical carbon dioxide. Initial results of the joint product development effort should be available later this year.

We are very excited about this opportunity and to be working with EMCM,” said CritiTech president Matthew McClorey. “They are a competent, focused and driven product development partner.”

This is the second major announcement from CritiTech over the last five weeks. On June 30th, CritiTech announced the successful completion of a Phase I Trial for its ovarian cancer drug, Nanotax®.

For more information about CritiTech, please visit www.crititech.com

 

Share

CritiTech Announces Positive Results from Phase I Trial of Nanotax® for Intraperitoneal Cancers

Human Health published Tue, 2014-07-01 09:04

LAWRENCE, KS – CritiTech, a growing drug delivery and development company, announced today positive results from the Phase I Trial of Nanotax® (“Trial”), a novel fine particle reformulation of paclitaxel to treat intraperitoneal cancers. The Trial, conducted at three clinical sites headed up by the National Cancer Institute Designated University of Kansas Cancer Center was designed to study the safety and pharmacokinetics in 21 patients with advanced peritoneal (“IP”) cancers.

“We are excited by the safety and pharmacokinetics outcomes from the Phase I Trial,” said Dr. Charles Decedue, Chief Scientific Officer at CritiTech. “The study results demonstrated that Nanotax® was very well tolerated, and there were no serious adverse events related to the drug. The data also showed evidence of high paclitaxel concentrations in the peritoneal cavity, extended drug release exposing tumors to higher concentrations of drug over a longer period of time, as well as substantially lower systemic exposure compared to intravenous injection of paclitaxel. With guidance from the U.S. Food and Drug Administration, we are looking forward to initiating the next steps to continue to advance Nanotax®.”

The safety and pharmacokinetic profile in the Phase I Trial is consistent with pre-clinical studies. In pre-clinical rat studies, Nanotax® had a ten-fold higher maximally tolerated dose compared to Taxol®. Delivered intraperitoneally in a mouse ovarian cancer model, Nanotax® significantly increased overall survival when compared to equal doses of Taxol®. In addition, substantially higher doses of Nanotax® compared to Taxol® could be delivered to the mice without noticeable toxicity.

About the Nanotax® Phase I Trial
Phase I Trial patients had relapsed solid IP tumors and adequate organ function. The primary malignancy was ovarian cancer (74%). Nanotax® was administered IP as a bolus injection after 500 ml saline followed by IP administration of up to 2 L of saline. The pharmacokinetics of IP administered Nanotax® were characterized in plasma and peritoneal fluid. Patients were treated at dose levels from 50 – 275mg/m2 every 28 days. Treatment was well tolerated. Pharmacokinetic data demonstrate significant, persistent IP exposure to Nanotax® at higher concentrations (~1,000X) compared to intravenous paclitaxel administration, with minimal systemic exposure and enhanced safety compared to Taxol®.
About Nanotax®


Nanotax® has been developed for the treatment of intraperitoneal carcinomas (e.g., ovarian cancer, pancreatic cancer, colorectal, liver, bladder, etc.) and is delivered via direct injection into the abdominal cavity. Nanotax®, is a Cremophor®-free, fine-particle reformulation of paclitaxel, developed by CritiTech using its proprietary fine-particle drug reformulation and production technology. Cremophor®, polyethoxylated castor oil, is the excipient used to deliver the poorly soluble paclitaxel (Taxol®) that is delivered intravenously. Some of the side effects associated with Taxol® include nausea, vomiting, diarrhea, blurred vision, difficulty swallowing, painful or difficult urination, ulcers or sores in the mouth, thinned or brittle hair, pain in the joints of the arms or legs, tingling in the hands or toes, unusual bruising or bleeding/pain/ redness/swelling/ blistering/infection/swelling at the injection site, change in normal bowel habits, fever, chills, cough, sore throat, difficulty swallowing, dizziness, shortness of breath, exhaustion, skin rash, itching, facial flushing, et. al. (see www.drugs.com).
CritiTech’s goal is to develop Nanotax® as a safer, better tolerated and more effective formulation of paclitaxel than those available on the market today

About CritiTech
CritiTech, Inc. is a drug delivery and development company focused on using the company’s proprietary Supercritical Fluid (“SCF”) Technology to help its clients and partners develop and manufacture unique and differentiated drugs and medical devices. CritiTech specializes in optimizing the delivery of challenging drug substances, potent molecules and poorly soluble compounds. By combining its SCF Technology with its ability to simplify formulations, CritiTech can expand and improve the drug delivery options for oral, injectable, and inhaled drugs, as well as implantable devices.

Share

Metactive Wins First Prize at the Medical Device Entrepreneur's Forum at the ASAIO 60th Annual Conference

Human Health published Tue, 2014-06-24 08:59

OLATHE, Kan.  Metactive Medical, Inc. ("Metactive") announced that it was awarded top prize in a business plan competition hosted by the Medical Device Entrepreneur's Forum, a special session held on June 20, 2014 at the ASAIO 60th Annual Conference in Washington, DC. F. Nicholas Franano, MD, President and Chief Executive Officer of Metactive, presented to a group of experts in medical device development and commercialization, venture capital, reimbursement, and regulatory affairs. Metactive placed first among a selected group of companies with innovative medical devices used for the treatment or diagnosis of disease.

 

"The role that ASAIO has played in bringing together a diverse group of creative and entrepreneurial scientists, engineers, clinicians, and industry representatives has been a critical factor in the development of a wide range of life saving technologies that we rely on today, including hemodialysis machines, ventricular assist devices, and extracorporeal membrane oxygenators, among many others," said Dr. Franano. "I know of no better place where medical device inventors and innovators can find fellow travelers, collaborators and friends. I'm honored that Metactive was recognized by this group."

 

About ASAIO

ASAIO (formerly known as the American Society for Artificial Internal Organs) is a premier society founded in 1955 for physicians, scientists, engineers, and entrepreneurs dedicated to the continually evolving fields of artificial organs, medical devices, and tissue engineering. For more information visit www.asaio.com.

 

About Metactive Medical

Metactive is developing novel endovascular medical devices for the treatment of neurovascular and peripheral vascular diseases. Metactive's first products enable precise and immediate occlusion and rapid sealing of cerebral aneurysms and other target vessel segments using an over-the-wire microcatheter platform. For more information, please visit www.metactivemedical.com.

 

Share

Aratana Therapeutics Initiates and Doses First Patient in Market Development Studies of AT-005 for Treating Canine T-cell Lymphoma

Animal Health published Fri, 2014-06-20 11:20

KANSAS CITY, Kan., Aratana Therapeutics, Inc., a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals, today announced that it is currently enrolling patients in two nationwide clinical trials to evaluate its monoclonal antibody for canine T-cell lymphoma, AT-005, which is conditionally licensed by the USDA to aid in the treatment of dogs with lymphoma.

These studies are not required by the USDA to obtain a full product license for AT-005, for which it is currently under review. They were designed by veterinary oncologists to evaluate AT-005 under real practice conditions, which will help Aratana and oncologists understand the clinical value of AT-005 once it is fully licensed by the USDA, which is anticipated to be in 2015. Specifically, the studies will evaluate AT-005 in combination with two different chemotherapy regimens used to treat dogs diagnosed with intermediate- to high-grade peripheral T-cell lymphoma. 

Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "Aratana is committed to demonstrating the full clinical potential of our novel pet biologics, which may offer veterinarians a new paradigm for treating lymphoma in dogs. In addition to the positive safety and efficacy data upon which the USDA based our product licenses for our canine lymphoma monoclonal antibodies, we believe the results of these two market development studies will be instrumental for demonstrating the potential benefit of adding a biologic to standard chemotherapy. Similar regimens have had meaningful impact on patient outcomes in human drug development, and we believe our ability to demonstrate a similar effect for AT-005 will facilitate its adoption by veterinarians and pet owners."

The studies are being conducted in coordination with Animal Clinical Investigation, LLC (ACI).

This study is currently enrolling patients.  For more information, please visit http://www.animalci.com/trials/t-lab .

Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The company's pipeline includes more than fifteen therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions.  Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets.  For more information, please visit www.aratana.com.

Share

IGXBio receives FDA approval to move forward with GenePro® clinical trials

Human Health published Tue, 2014-06-17 17:29

Lenexa, KS – IGXBio, Inc. has received approval from U.S. Food and Drug Administration (FDA) to begin human clinical trials of GenePro®, a DNA-based HIV vaccine.

Jim Laufenberg, Co-Founder and CEO of IGXBio stated, “This is a very exciting time for the company, and achieving this milestone allows us to proceed with first in-man studies in HIV positive individuals”.
 
IGXBio, formerly known as Immunogenetix Therapeutics, has also received angel investment from the Mid-America Angels and funding from the State of Kansas. To date, the company has received $4,625,000 in capital funding to develop its DNA therapies. In addition, the National Institutes of Health has provided $21,000,000 in grants to the development of GenePro®.


About IGXBio
IGXBio, Inc. is a clinical-stage biotechnology company developing DNA therapies for the treatment of viral infections with a focus on HIV. The company's proprietary lead candidate, GenePro®, has published efficacy studies in non-human primates with promising results. The incidence for HIV/AIDS is estimated at 1.1 million in the U.S. and growing. Due to drug resistance developing in the use of current antiretroviral drug therapy, along with an increase in serious adverse effects, there is a large demand for immune modulating drugs such as GenePro®. For more information please visit: IGXBio.com.

 

Share

Aratana Therapeutics licenses new stem cell therapy for arthritis in dogs

Animal Health published Fri, 2014-06-13 15:19

Aratana Therapeutics Inc. has licensed a new stem cell therapy that it plans to develop to treat osteoarthritis in dogs.

The agreement grants the Kansas City, Kan., animal health company the exclusive rights to commercialize the therapy from Vet-Stem Inc., a California veterinary regenerative medicine company.

Vet-Stem, according to a release, pioneered a process in which fat tissue is harvested from a patient before stem cells are isolated and then reintroduced back into that patient. The company also has developed a technology in which a single donor sample can be used to generate doses that can be stored and used to treat a number of patients.

Aratana licensed that therapy, which it will test for safety and efficacy in treating osteoarthritis in dogs.

"As we continue to build our pipeline, we have made a clear strategic investment in the high-need area of pain management for our pets," Aratana CEO Steven St. Peter said in a statement. "We therefore are pleased to expand our pain franchise further by adding an allogeneic, regenerative cell therapy product, which in addition to its aim of reducing the pain of osteoarthritis, has the potential to impact the progression of the disease, and to promote tissue regeneration. We will examine this phenomenon in planned studies, which could result in product labeling that specifies disease-modifying properties."

 

- The Kansas City Business Journal

 

Share

Flow Forward Announces Spinout from Novita

Human Health published Thu, 2014-05-29 10:02

Flow Forward Medical, Inc., an early-stage medical device company focused on improving outcomes for hemodialysis patients through the rapid creation of high-quality vascular access sites, today announced that it has launched operations as an independent company at the Venture Accelerator in the Kansas Bioscience Park in Olathe. Flow Forward was initially founded in 2011 as a subsidiary of Novita Therapeutics, LLC, a privately held life sciences incubator.
 

"Flow Forward is focused on developing the AFE System, which has the potential to substantially increase the number of hemodialysis patients using an arteriovenous fistula (AVF), the gold standard in vascular access sites," said F. Nicholas Franano, MD, chief executive officer of Flow Forward. "Currently, many patients are unable to get a functional AVF due to inadequate vein size and poor vein maturation, and we believe our system can help overcome these problems."
 

Hemodialysis is a lifesaving treatment for end-stage renal disease (ESRD) that requires the patient to have a vascular access site. The preferred type of site for hemodialysis patients is an AVF, due to improved patient survival, reduced complications and hospitalization rates, and large reductions in the cost of care when compared with other forms of access. However, nearly half of U.S. hemodialysis patients do not currently use an AVF for vascular access, primarily due to inadequate vein diameter and high rates of AVF failure.

Flow Forward's Arteriovenous Fistula Eligibility (AFE) System™ is a small, temporary, minimally-invasive blood pump designed to rapidly dilate peripheral veins through flow-mediated dilation prior to AVF surgery.  Use of the AFE System could increase patient eligibility for AVF and improve success rates after AVF surgery. In a recent presentation at the American Society of Nephrology annual meeting, Flow Forward reported results of a small pilot nonclinical study showing vein dilation 20 times faster and a large reduction in vascular scar tissue formation during vein maturation, when compared with traditional AVF creation.

“This represents real innovation,” said Tom Krol, Managing Director at the Kansas Bioscience Authority and a Flow Forward investor and director, “with the potential to deliver benefits to patients that would not have previously been thought possible.” “Successful development and commercialization of the AFE System could begin to alleviate some of the enormous burden that vascular access failure places on patients, health care providers, and payers”, said Krol, “and that makes the work at Flow Forward both an important effort and an attractive investment for KBA.”

 

About Flow Forward Medical

Flow Forward is developing a novel approach to rapidly establish high-quality vascular access sites for hemodialysis. The AFE System is a small, temporary, external blood pump designed to stimulate flow-mediated dilation to make more patients eligible for an arteriovenous fistula (AVF) and increase success rates after surgery. Establishment of a reliable AVF reduces morbidity and mortality in hemodialysis patients, as well as the overall cost of care. For additional information, please visit www.flowforwardmedical.com.

 

Share

Aratana Therapeutics Reports First Quarter 2014 Results

Animal Health published Tue, 2014-06-03 16:21

KANSAS CITY, Kan., -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals, today announced its first quarter 2014 financial results.

"Aratana continues to advance its deep pipeline of therapeutics focused on treating serious diseases in pets," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "We are establishing ourselves as a leader in the rapidly evolving pet therapeutics industry."

 

Click here to view report.

 

 

 

 

 

Share

Metactive Debuts Novel Embolization Technology

Human Health published Sun, 2014-03-23 10:03

Metactive Medical, Inc., an early-stage company focused on developing endovascular embolization devices for the treatment of neurovascular and peripheral vascular diseases, today presented new nonclinical data on one of its investigational devices at the Society of Interventional Radiology's (SIR) Annual Scientific Meeting. Metactive currently has two devices under development, and today's presentation focused on the company's device that addresses the cerebral aneurysm market. The company's chief executive officer, F. Nicholas Franano, MD, made an oral presentation entitled "Over-the-wire Device for Immediate, Complete and Durable Occlusion of Saccular Cerebral Aneurysms" during the "Arterial Aneurysms and Dissection" session at the meeting.
 

 

"Endovascular embolization of cerebral aneurysms with coils was a major advance when it was introduced more than 20 years ago," said Dr. Franano. "The technology that we are developing at Metactive builds upon that innovation by providing a next-generation device that has the potential to provide better patient outcomes, to be faster and easier for physicians to use, and to improve hospital profitability."
 

 

Physicians treat approximately 280,000 aneurysms per year worldwide using surgical clips, endovascular coils and flow-diverting stents. Current treatments are complex and costly, and do not consistently result in complete and permanent occlusion of aneurysms. At SIR today, Metactive presented findings from a recent pilot nonclinical study in which the company's cerebral aneurysm embolic device demonstrated immediate and complete mechanical occlusion of a large, terminal saccular aneurysm, as well as full endothelialization and sealing of the aneurysm neck at one month. By comparison, in the same aneurysm model, treatment using widely used conventional coils did not provide immediate and complete occlusion. Compared to coiling, the procedure to place Metactive's device took half as long, and the devices cost one-third as much. While Metactive has only completed a handful of nonclinical procedures to date, these excellent early results support further investigation.
 

 

"If Metactive can demonstrate that this new device can provide better clinical outcomes with much lower procedure time and complexity, and large reductions in cost, then I believe it has the potential to provide real value for patients, physicians, hospitals and payers -- especially for large aneurysms," said Kieran Murphy, MD, interventional neuroradiologist and professor of radiology at the University Health Network Toronto in Ontario, Canada, and director of clinical faculty at the Techna Research Institute.
 

Share

Terratek® Flex, the Market’s First Compostable Elastomeric Bioplastic

Agribusiness published Wed, 2014-03-12 10:43

Terratek® Flex, the market’s first compostable elastomeric bioplastic, can be used as an impact modifier for polylactic acid (PLA), increasing impact strength, elongation and flexibility without sacrificing compostability.

Green Dot’s Product Development Manager, Mike Parker, will present his findings on the efficacy of Terratek® Flex as an impact modifier for PLA at the the Global Plastics Environmental Conference (GPEC) in Orlando, Florida on March 13, 2014. Mr. Parker analyzed the physical properties of PLA modified with Terratek® Flex over a range of loading ratios. He will discus how levels of Terratek® Flex can be customized to achieve desired cost and performance.

Terratek® Flex is the market’s first elastomeric bioplastic to be certified to meet U.S. (ASTM D6400) and E.U. (EN 13432) standards for compostability. The rubber-like material is strong, durable and pliable. It has been tested by NSF International laboratories to be free from phthalates, bisphenol A, lead and cadmium. When compounded with PLA, Terratek® Flex can enhance physical properties, increasing impact strength, elongation and flexibility without sacrificing compostability.

GPEC is presented by the Society of Plastics Engineers’ (SPE) Plastic Environmental Division (PED). The conference focuses on the unique blend of recycling, reclamation and bioplastics.  

About Green Dot Holdings LLC - Green Dot is a bioscience social enterprise headquartered in Cottonwood Falls, Kansas. The company serves the plastics industry and style conscious consumers with a full line of biobased and compostable materials sold under the Terratek® brand name. Green Dot aspires to improve the environment in which we live by building a more sustainable world with renewable biobased resins and promoting their use through invention, creation and research. Learn more at www.GreenDotPure.com.

Share

Health Outcomes Sciences Completes First Close of Series A Preferred Financing

Human Health published Wed, 2014-03-05 22:09

Kansas Bioscience Authority, Grayhawk Venture Fund II Lead Round

Health Outcomes Sciences Inc. (HOS), a leading health care IT company based in Overland Park, Kan., today announced that it has completed the first close of its Series A Preferred financing round. The company has raised $5 million in the first closing and expects to raise up to an additional $2 million of capital, bringing the round to $7 million.

The round, which is led by the Kansas Bioscience Authority (KBA) and Grayhawk Venture Fund II (GVFII), also includes a broad representation of existing angel investors. The funds will be used to grow sales of the company’s ePRISM® clinical decision support software, which provides evidence-based individualized risk models to physicians where they need them most, at the point of care.   

“We are thrilled to have KBA and Grayhawk join us in our pursuit to impact the cost-quality paradox in health care,” said Matt Wilson, HOS president and CEO. “HOS is among the first to capitalize on a huge market for technologies capable of personalizing patient analytics and applying them in direct clinical care. This round of funding will help us build on our early success in cardiology and extend our reach to other specialties.”

Keith Harrington, KBA managing director, said, “KBA is delighted to partner with the Health Outcomes Sciences team to accelerate the company’s sales growth and improve patient outcomes. This is a great example of a Kansas-based, world-class life sciences company doing important work throughout the U.S.”  

Brian Burns, GVFII partner, added, “HOS is at the leading edge of using big data for supporting medical decisions. We are excited to be a part of a company that can improve both health outcomes and cost containment in hospitals.”

Share

Metactive Announces Spinout from Novita

Human Health published Fri, 2014-02-21 08:56

Metactive Medical, Inc., an early-stage company focused on developing embolization devices for the treatment of peripheral vascular and neurovascular diseases, today announced that it has launched operations as an independent company at the Venture Accelerator in the Kansas Bioscience Park in Olathe. Metactive was initially founded in 2012 as a subsidiary of Novita Therapeutics, LLC, a privately held medical device incubator. At the present time, the Company has two products under development.

 

Metactive's first product addresses the peripheral artery embolization market, where physicians perform about 180,000 procedures per year worldwide using vascular coils and plugs. In a recent pilot nonclinical study, Metactive's peripheral embolic product demonstrated immediate post-deployment vascular occlusion in all seven cases, while a leading competitive plug product did not demonstrate immediate occlusion in any of three cases. Metactive's product maintained complete occlusion in all cases at 28 days, while the same leading competitive product was unable to maintain occlusion in any cases.

 

"Clinicians who perform peripheral embolization have been asking for an over-the-wire embolic device on a microcatheter platform that is easy to use and can provide immediate, complete, and durable occlusion," said Metactive CEO, F. Nicholas Franano, MD. "We believe we have built a product that meets those specifications and are moving forward to make it available to physicians who want it and patients who need it."

 

Metactive's second product addresses the cerebral aneurysm market, where physicians treat about 280,000 aneurysms per year worldwide using surgical clips, vascular coils, and flow-diverting stents. In a pilot nonclinical study, Metactive's cerebral aneurysm embolic product demonstrated immediate occlusion of a large, terminal saccular aneurysm and full sealing and endothelialization of the aneurysm neck at one month. The Metactive product provided immediate and complete occlusion, which the widely used coil treatment did not provide in the same aneurysm model. Metactive's product also demonstrated a 50% reduction in procedure time and a 60% reduction in device cost when compared with coiling.

 

"Endovascular embolization of cerebral aneurysms with coils was a major advance when it was introduced more than twenty years ago," commented Dr. Franano. "The product we have developed at Metactive builds upon that innovation by providing a next-generation device that has the potential to be better for patients, faster and easier for physicians to use, and less expensive for payers."

 

"When managing life-threating situations, physicians need the best tools available to deal with the situation quickly and effectively," said Tom Krol, Managing Director at Kansas Bioscience Authority and a Metactive investor and member of the Board of Directors. "Metactive is developing new and highly effective devices to add to that the toolbox, ones we think physicians will reach for first in these situations."

 

Share

Aratana gains conditional approval for cancer drug

Animal Health published Tue, 2014-01-28 09:42

Aratana Therapeutics Inc. announced Tuesday that it has gained conditional approval to begin marketing a drug designed to treat cancer in dogs.

The USDA grants conditional approval for animal drugs that are proven to be safe but that have not yet been proven to be effective. However, there must be a "reasonable expectation" that the drug is effective.

This product, called AT-005 targeting T-cell lymphoma, is Aratana's second drug to gain that license.

A drug that is designed to treat B-cell lymphoma, called AT-004, gained that designation in 2012 and is currently licensed to Novartis Animal Health Inc.

Aratana acquired both drugs during the company's merger with San Diego company Vet Therapeutics Inc. in October 2013.

"We are proud to achieve our first regulatory milestone following the acquisition of Vet Therapeutics' pet biologics platform, which brings us closer to market with our first internal commercial opportunity," CEO Steven St. Peter said in a statement. "Conditional approval by the USDA for AT-005 is also a major milestone for our dog lymphoma franchise as a whole, which we believe is poised to redefine the treatment of this important disease that affects millions of dogs worldwide."

The company will now focus on gaining full licenses from the USDA for both products.

 

 

- Kansas City Business Journal Jan. 28, 2014

Share

HDL, Inc. Acquires Exclusive U.S. License For Early Lung Cancer Detection Test From Oncimmune Ltd.

Human Health published Tue, 2013-10-29 14:52

Virginia-based Health Diagnostic Laboratory, Inc. will acquire and operate Oncimmune’s DeSoto, Kansas lab and become  the exclusive licensed U.S. provider of EarlyCDT®- Lung, the world’s first autoantibody test for early detection of lung cancer.

“KBA was an early investor in Oncimmune USA in 2006, investing $2 million in a convertible note to help the company establish its CLIA lab operation in De Soto, KS.  We are delighted at this outcome and look forward to the continued success of the EarlyCDT-Lung test,” said Keith Harrington, KBA Director of Commercialization.

“Oncimmune’s subsidiary in the U.S. has been building sales and awareness of the EarlyCDT-Lung test on a steady basis for the past few years,” said Geoffrey Hamilton-Fairley, Executive Chairman of Oncimmune Ltd. “By licensing our first test to HDL, we have secured access to a distribution channel that will deliver greater volume more quickly and at the same time provide sufficient revenues so that the company can accelerate the launch of our other early cancer detection tests.”

Lung cancer is the leading cause of cancer deaths among men and women in the U.S., taking the lives of more people each year than colon, breast, prostate, and pancreatic cancers combined. Lung cancer claims more than three times as many men as prostate cancer and nearly twice as many women as breast cancer. The American Cancer Society predicts that in 2013 there will be approximately 228,000 new cases of lung cancer diagnosed and nearly 160,000 lung cancer associated deaths

Oncimmune USA’s 25 employees will join the 740-employee HDL, Inc. and will remain in the De Soto location as of the closing date for the transaction.

Share

Aratana Therapeutics is the recipient of KBA Investment

Animal Health published Wed, 2013-02-06 13:54

OLATHE, Kan. (February 6, 2013) – Aratana Therapeutics is the recipient of a $324,148 investment by the Kansas Bioscience Authority. Previously code-named “Project Gray,” the funding was unanimously approved by the Board of Directors on January 22, 2013.  Aratana requested that the details of this investment be kept confidential until the fundraising round closed.

Aratana Therapeutics is an animal health drug development company that delivers high-quality, new medicines for unmet needs in animal health.  Established in December 2010 in Kansas City, Kan., the company licenses and develops proprietary, patent-protected compounds acquired from human pharmaceutical and biotechnology companies.

The KBA funds will be invested in their Series C Preferred Stock to maintain the Authority’s ownership stake.

“This Series C offering gives the KBA the opportunity to provide important follow-on capital to one of the most successful equity investments in our portfolio,” said Duane Cantrell, KBA President and CEO.   “The initial investment in Aratana Therapeutics three years ago was successful in yielding $30 million in new equity investment in the state, which led to new jobs, increased research spending and the attraction of new animal health companies to Kansas.”

Share

Subscribe Via RSS

Recent Blog Posts

By Sector

Bioenergy Animal Health Human Health

Archive

2014

2013

2012

2011