A Medical Device Daily

Bio-Matrix Scientific (San Diego), a biotech company focused on stem cell cryogenics and disposable stem cell/tissue transfer instruments, said it has entered into a contract with Validation Systems (VSI; Palo Alto, California) to complete and finalize its FDA Good Manufacturing Practices (cGMP) Quality Systems documentation. Once this documentation is finalized and the company receives clearance from the State of California, stem cell specimens can be cryogenically stored.

Bio-Matrix said it intends to open what it believes to be the first commercial adult stem cell processing and banking facility in the world for harvesting stem cells from adipose tissue, calling this a "new dimension" in stem cell banking.

VSI is a validation contractor and laboratory service provider serving the pharma, biotech and device industries since 1990.

VSI will provide Bio-Matrix with validation and technical services for its cGTP (Good Tissue Practices) and cGMP for the processing and cryo-storage, in liquid nitrogen, of adult stem cells.

"We believe our relationship with VSI represents the last piece in completing our goal of getting the facility open," said Dr. David Koos, CEO and chairman of Bio-Matrix. "Once VSI and Bio-Matrix finalize the quality systems documentation and we gain the anticipated regulatory approvals, we can then implement our business model — moving towards revenue."

In other contract news:

• Solectron (Milpitas, California), a provider of electronic supply chain services including design, manufacturing and aftermarket services, finalized an agreement with CSA Medical (Baltimore) to manufacture the company's CryoSpray Ablation system.

CSA developed the CryoSpray Ablation system, which freezes and destroys unwanted tissues found in the esophagus, which, according to various reports, arises from acid reflux.

"We needed a contract manufacturing partner with deep medical device expertise, complex systems mastery, and end-to-end manufacturing and supply chain capabilities," said Freddy Cannady, VP, Operations, CSA Medical.

CSA's focus is bringing the proven science of cryotherapy to Endoscopy.

• HemoBioTech (Dallas) reported retaining Ronald Trahan Associates (Westwood, Massachusetts) for public relations and investor relations services. RTA focuses on serving the life sciences Industry.

HemoBioTech is developing HemoTech, a blood substitute technology licensed from the health sciences center of Texas Tech University (Lubbock).