Monday 31 July 2017

CEO Interview with Uptick Radio Details Commercial Progress

Our President and CEO Dennis Calvert appeared on the Uptick Newswire Stock Day Radio Show late last week to review the company's steadfast march to commercial success. For a direct link to the interview, go here.

If you're pressed for time, here are some of the important points of the interview:

CupriDyne Clean:
  • BioLargo's subsidiary Odor-No-More has signed three national purchasing agreements with leading US solid waste management companies for its CupriDyne Clean Industrial Odor Eliminator in the past few months, paving the way for increased sales.
  • The market is primed by the numerous successful commercial trials CupriDyne Clean has enjoyed with solid waste handling facilities.
  • Sales are climbing.
Industrial Odor Control Market:
  • Huge market for industrial odor control in the US and Canada.
  • There are ~15,000 direct potential landfill customer facilities in the US.
  • Target Customers' purchase volumes can range from ~2-20K each.
Clyra Medical Technologies:
  • The last year saw investment and development wrap up for our disruptive wound care products.
  • Pre-approval testing has been done.
  • On-track for FDA 510K application, in a matter of weeks. 
  • Clyra's wound care products' testing results shown at conference in Puerto Rico by Dr. Brock Liden.
AOS August Symposium:
  • Results will be shown for commercial validation trials done with the Alpha AOS showcased at last year's symposium. These trials were done with industrial poultry wastewater, dairy wastewater, and municipal secondary effluent wastewater.
    • Can't stress enough how important these results will be for commercial adoption!
  • Development process for the AOS commercial prototype will be presented.
  • The AOS is the high-value low-cost solution to very serious problems in the water industry - it hits contaminants that competing technologies cannot, and does it while using shockingly little energy.

Friday 28 July 2017

BioLargo a Finalist for OCTANe High Tech Innovation Award

BioLargo, Inc. President and CEO Dennis Calvert was recently interviewed by OCTANe OC, a leading innovation cluster based in Orange County, on BioLargo’s technology, its vision, and its strategy to achieve future growth. The interview was part of a comprehensive assessment for OCTANe’s High Tech Innovation Award (HTIA), a prestigious industry award that recognizes outstanding technology innovators in Orange County. 

We’re excited to announce that BioLargo has been chosen as a finalist for this year’s (2017) OCTANe HTIA award. It’s no surprise that the company was not only nominated, but also made a finalist this year – 2017 has been a year of tremendous progress for BioLargo, both technologically and commercially. Its subsidiary, Odor-No-More, signed multiple national purchasing agreements with some of the largest solid waste management companies in North America this year for its industrial odor control product CupriDyne Clean, signalling meaningful commercial traction in this large and underserved market. Clyra Medical Technologies, another BioLargo subsidiary, completed development of its iodine-based advanced wound care products and is preparing submission for its product for FDA 510(K) application in the near future. And importantly, BioLargo’s Advanced Oxidation System (AOS) made significant strides toward commercialization, with more than 35 awarded grants, 3 commercial validation trials underway and potential engineering and scale-up partners under evaluation.

BioLargo AOS being tested in the lab

Dennis P. Calvert, President & CEO of BioLargo commented, “OCTANEe is building a dynamic ecosystem in Orange County to support technology innovation like ours.   We are proud to be chosen by such a prestigious group of companies. 

Other finalists for this year’s HTIA award include well-known computer technology companies such as HyperX and D-LINK, along with innovative biotechnology, medical, and software companies. Clearly, 2017 yielded an impressive list of finalists. For a full list of OCTANe HTIA finalists, go here.

Monday 17 July 2017

BioLargo’s Clyra Medical Subsidiary on Track to File 510K with FDA for Novel Wound Care Products

Tamarack Advisers recently published an article focused on Clyra Medical Technologies' exciting presentation at the Peter Sheehan Wound Healing: Science & Industry Conference in San Juan, Puerto Rico. 


A year and a half ago, BioLargo, Inc. (OTC: BLGO) announced that its Clyra Medical division secured financing to advance its novel wound care products.  Steve Harrison, President of Clyra Medical Technologies, then commented, "We believe this financing will provide the capital needed to help Clyra secure the regulatory approvals and launch what we believe will become a game changer for the Advanced Wound Care industry. This is a fast-growing $8 to $10 billion market in which we believe we will be able to offer better and more cost-effective solutions.”

Last month, Clyra Medical presented their breakthrough products at the 15th annual Peter Sheehan Wound Healing: Science & Industry Conference in Puerto Rico that was attended by leading wound care clinicians and researchers. We had a chance to speak with Mr. Harrison who reported, “We are highly encouraged by the overwhelming positive response from the clinical wound care experts attending the conference.  The data from the FDA pre-submission testing generated a great deal of enthusiasm among the leading clinicians and researchers at the conference.  The required pre-submission studies were conducted by Nelson Labs, an independent third party that is recognized as one of the leaders in laboratory testing for FDA submissions.”

The presentation at the conference highlighted Clyra’s advantages over existing wound care products:

  • Clyra’s hydrogel wound dressings and wound wash are highly effective and have no known antimicrobial resistance
  • GLP lab studies demonstrated sustained release and continued antimicrobial effectiveness against major organisms
  • Effective against biofilm in laboratory controlled in vivo pig studies has shown effectiveness against mature biofilm, with better results than certain prescription antimicrobial solutions
  • Non cytotoxic, non-sensitizing, and safe to human cells
  • Can easily integrate Clyra technologies into existing products and new ones in the pipeline including regenerative tissue
Dr. Brock Liden, DPM, a wound care expert with an extensive wound and limb salvage practice in Ohio presented the latest Clyra data to the conference. He commented “When I was introduced to the Clyra technology I was very interested to learn more. This is a complex that has been shown to impact bacteria, and show sustained activity, yet be safe to cells and the wound healing process. It may have clinical application to be used with cellular tissue products, stem cells, and growth factors with no harm to the modality. This is a significant breakthrough in the wound space. With further clinical research we may even have a modality to impact established biofilms while doing no harm to the host or the healing modalities being utilized.  As I learn more about Clyra’s technology, I feel that it has the potential to have a significant impact in wound care as well as potential in other areas of medicine”

On the flip side of their enthusiasm is that Clyra is keenly aware of the stiff competition they will face in the wound care industry.  One established competitor offering a broad line of wound care products is Smith & Nephew (NYSE: SNN).  Another is Osiris Therapeutics (NASDAQ: OSIR) that offers regenerative medicine products for difficult to treat acute and chronic wounds.

Clyra has retained Emergo, a global firm specializing in medical device regulatory consulting, to prepare its FDA filings, and reports they are on track for filing in the very near future. With the relatively short turnaround times for 510k submissions and the ongoing need for better wound care products, it is possible that Clyra’s powerful, gentle and long-lasting products may soon find themselves entering the rewarding stage of commercialization.

** Corrected Version 7-18-2017

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SOURCE: Tamarack Advisors
For a link to the original article go here!