SAN DIEGO -- (BUSINESS WIRE) -- KESA Partners is pleased to announce the formation of NuCollagen LLC, based in San Diego, CA. NuCollagen will manufacture laboratory and medical grade cGMP bovine collagen for the medical device, in-vitro diagnostic and regenerative medicine markets. NuCollagen will partner with Bioserv Corporation and Stratum Medical for manufacturing and analytical services.
In addition, KESA Partners has appointed Larry Braga as President of NuCollagen. Mr. Braga has an extensive background in medical grade bovine collagen development and manufacturing and most recently was instrumental in the manufacture of collagen-based permanent injectable wrinkle filler, ArteFill® and previously supported the launch of several other bovine collagen-based commercial products, including Collagraft® CoStasis® and Contigen®. “NuCollagen’s plan is to provide our customers medical grade bovine collagen derived from an established U.S. closed herd that can be customized to our customers’ exact specifications. Our current plan includes a pilot scale laboratory grade purified collagen manufacturing facility, which will be fully operational in the first quarter of 2014. Following a cGMP plant build-out, medical grade collagen will be made available by the end of 2014”, states Mr. Braga.
Al Hansen, Managing Partner of KESA Partners, comments, “This is an exciting opportunity for KESA and we are fortunate to have someone with Mr. Braga’s background in bovine collagen commercial manufacturing, as it is quite challenging to manufacture medical grade collagen to FDA and international standards. KESA Partners realizes there is a shortage in the supply of medical grade collagen for the U.S. and international markets, primarily due to a major U.S. manufacturer’s decision to end supplies to its OEM customers.”
In addition, NuCollagen has reached an agreement to develop medical grade bovine collagen for AscentX Medical Inc. and also manufacture its clinical trial product G125 injectable bulking agent to support their pending European clinical trial. “A strategic partnership with NuCollagen, which agreed to manufacture our collagen/PMMA-based G125 injectable bulking agent for the endoscopic treatment of GERD, presents a unique opportunity for AscentX to focus its capital and expertise on the clinical development of its lead product candidate G125. We are looking forward to a mutually beneficial and value-creating collaboration between the two companies,” said Stefan Lemperle, MD, PhD, president & CEO of AscentX Medical Inc.
Notes to Editors:
About KESA Partners
KESA Partners, based in Newport Beach, CA, seeks small company equity investment opportunities in pharma-related companies where it can lead investments of small capital financing rounds ($100k - $3 million). KESA often partners with existing shareholders to benefit from unusual capital appreciation opportunities. These companies typically are somewhat established but often have difficulties to understand complex business models/opportunities. Such businesses often require some capital and/or strengthened management. If a management change is necessary, KESA Partners can provide interim management services while recruiting permanent management teams, often through its extensive existing network.
About Bioserv Corporation
Bioserv Corporation, located in San Diego, USA, was founded in 1988 as a small boutique contract manufacturing organization servicing the pharmaceutical, medical diagnostics, medical device, biotechnology, and life science reagents industries. With over 35,000 square feet of manufacturing facilities, Bioserv’s core competencies include aseptic and non-aseptic bulk formulation, filtration, fill and finish, lyophilization services, labeling, finished goods assembly, kitting and packaging, as well as controlled temperature storage and distribution services. (www.bioservamerica.com)
About Stratum Medical Corporation
Stratum Medical Corporation is a privately held development company that specializes in the commercial development of synthetic peptides including formulation development, analytical development, fill and finish, project management and offers expertise in pre-formulation and formulation development, lyophilization cycle development, analytical method development and qualification, method validation, quality control, stability testing, test article preparation for toxicology testing and animal studies, and other technical support needed in the development of peptide pharmaceutical and medical device products. (www.stratummedical.com)
About AscentX Medical
AscentX Medical is a privately-held development-stage medical technology company focusing on the clinical development of G125 for cost-effective endoscopic outpatient treatment of gastro-esophageal reflux disease (GERD). G125 is a unique permanent injectable bulking agent specifically designed to re-establish the physiologic barrier function of the lower esophageal sphincter (LES) to prevent acid reflux and consists of bovine collagen and polymethylmethacrylate (PMMA) microspheres. Additional product candidates are based on the same technology platform and include U125 for the treatment of female stress urinary incontinence and F125 for the treatment of fecal incontinence. (www.ascentxmedical.com)
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