Posts tagged OTC
American CryoStem pioneering adipose tissue stem cell technologies

American CryoStem (OTC:CRYO) has developed platform technologies dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue and adipose derived stem cells (ADSCs) for current or future use in regenerative medicine.

Read More
BioSyent to target international markets

BioSyent (OTC:BIOYF; TSX-V:RX) is actively building its international pharmaceutical sales and marketing business, adding products licensed and sold internationally to products already being shipped from Canada.

“We’re working on a couple of international deals now,” René Goehrum, chairman, president and CEO, says in an interview with BioTuesdays.com.

Mr. Goehrum explains that BioSyent hopes to commercialize new product deals in the Middle East, Latin America and Southeast Asia. “These products may not be licensed for sale in Canada.”

Read More
Peritech readies U.S. launch of novel hemorrhoid gel

Closely-held Peritech Pharma of Israel is in discussions with potential marketing partners for a U.S. launch of its once-daily over-the-counter gel, now known as PP-110, for the treatment of hemorrhoids.

“PP-110 contains the same active pharmaceutical ingredients as Pfizer’s Preparation-H cream: pramoxine-HCI 1% and phenylephrine-HCI 0.25%,” Raveh Gill-More, VP of business development, says in an interview with BioTuesdays.com.

“The differentiation with our product is the non-active ingredients, namely our film-forming formulation and slow release mechanism, leading to a long-acting effect,” he adds.

Read More
Regenicin readying clinical trials of NovaDerm skin substitute

Regenicin (OTC:RGIN) is completing validation of its NovaDerm skin substitute at a leading institute of technology in the U.S and plans to seek FDA approval to move into clinical trials in the second half of 2015 as well as file for worldwide designation of NovaDerm as an orphan product.

“We expect to be in the clinic before the end of the year at one or two of the 150 critical burn centers in the U.S.,” Randall McCoy, chairman and CEO, says in an interview with BioTuesdays.com.

The clinical trial is expected to enroll a minimum number of burn patients, with each patient completing treatment in three months. “We expect the FDA will ask us to monitor the patient for six months to see if we can obtain additional benefits about the performance of NovaDerm. That should put us on track to file for regulatory approval before the end of 2016,” he adds.

Read More
Encision to launch simplified AEM device

The new management team at Encision (OTC:ECIA) plans to launch in late spring a simplified version of its Active Electrode Monitoring (AEM) technology, known as the EndoShield Burn Protection System, to continuously monitor laparoscopic surgical instruments for stray burns and eliminate that risk to patients.

“We realized that we had to make our product simpler, take the capital equipment cost out of the equation and develop a product that would give us recurring revenue per procedure,” chairman Dr. Patrick Pace says in an interview with BioTuesdays.com.

Earlier this month, Boulder, CO-based Encision filed a premarket 510(k) notification with the FDA of its intent to market EndoShield, which integrates the AEM technology into a disposable smart cord and eliminates the need for a separate AEM monitor.

Read More