calzada - inventory of current projects

Although the market has not yet taken note, the Calzada story has recently become significantly more compelling. The company has several projects ongoing and making progress.

Let’s review:

First, on the PolyNovo side of the house:

1- On April 17, extraordinary clinical trial results were announced for the NovoSorb™ NPT dressing. Although the protocols for the US FDA’s 510 k) pathway to marketing approval do not require human clinical trial results, the fact that they have been developed and are so convincingly positive, bodes well for a prompt approval action.

Meanwhile, and in parallel to the 510 k) application, the company has said that “The Company is currently progressing these commercialisation activities.”

There are compelling reasons to conclude that these commercialization activities may result in an agreement in the relatively near term, as outlined in my longer post on this subject.

The successful commercialization of this technology will be certain to result in a major revaluation of CZD. The market in the US alone for this product is over $300 million annually.

2- Human trials of the Bio Temporizing Matrix (BTM) in surgical wound repair are progressing well, as announced by the company on February 18. No one can look at the results of the BTM implantation depicted in the annoucement without coming away very impressed. We also note Dr. Greenwood’s comment “These early results have encouraged the plastic surgeons involved to allow its use on the most commonly used free flap (radial forearm flap) procedures, which should markedly increase the number of patients suitable for recruitment”.

Upon completion of these current trials, the company will submit a 510 k) application to the US FDA for this product as well. There is every reason to expect a positive result from this marketing application.

3- Also on February 18, the company announced that the Barda grant application remains under evaluation, but due to the priorities of BARDA, only the BTM product and application will be evaluated for use in mass burn events.
Sadly, the events in Boston last week underscore the need for a rapidly deployable burn treatment that is robust, easy and uncomplicated to implement, and offering reliable outcomes.

If awarded as expected, the BARDA grant will provide yet another major validation of the NovoSorb technology.

4- The NovoSkin project continues to progress through animal studies and as this extraordinary technology continues to mature if offers the prospect of a treatment of severe burns that does not rely on painful and time-consuming skin grafts.

5- Development of bone fixation and bone cements through partnership with Smith and Nephew continues satisfactorily.

On the Metabolic Pharmaceuticals side:

6- AOD9604 has been granted conditional GRAS status in the United States, subject only to the publication of existing safety data. Publication of this data is being arranged currently. Once approved, AOD9604 can be marketed in the United States as a food additive and dietary supplement. Commercialization efforts are ongoing in parallel to removing the conditionality attached to the GRAS status.

Market interest in reasonably priced AOD9604 intended for the food supplement industry is substantial.

7- On February 5, the company announced results achieved by Dr.
Dong Rak Kwon at the Daegu Catholic University Medical Center, Daegu, Korea demonstrating the safety and efficacy of AOD9604 in the repair of cartilage and joint tissue in an osteoarthritis animal model.

8- In vitro research by Professor Marc Grynpas at Mt Sinai Hospital, Toronto, Canada has provided evidence that AOD9604 has a positive (anabolic) effect on cartilage tissue formation, and was found to enhance cartilage tissue formation by increasing the proteoglycan (cellular matrix) and collagen content of cartilage. AOD9604 also was found to enhance the differentiation of muscle progenitor cells (cells that create muscle cells) to muscle cells. No cell toxicity was found. I believe that Professor Grynpas’ research is continuing.

The immediate future of Calzada is tied closely to the success of commercialisation of the NovoSorb™ NPT dressing. Fortunately, this appears to me at least to have a rather high chance of success for the reasons outlined in my earlier post on this specific subject.