Wednesday, January 20, 2021 8:37:32 AM
SinuSys reports that chronic sinusitis affects more than 31 million people in the United States and that it is more prevalent than heart disease or asthma and has a greater impact on patients' quality of life than chronic back pain or congestive heart failure. The majority of patients with chronic sinusitis are treated with oral antibiotics and/or nasal steroids, which can increase the risk of antibiotic resistance and cause unwanted side effects such as nose bleeds, nasal ulcers, and nasal and oral infections. The most effective sinusitis treatment is Functional Endoscopic Sinus Surgery (FESS) with rapid balloon dilation at high pressures, which is known to cause significant patient discomfort and is conducted in a surgical suite under general anesthesia or IV sedation. Annually, it is estimated that $11 billion is spent in the U.S. alone on improving the health of patients with sinus conditions.
SinuSys Corporation, a medical device company focused on developing new therapies to improve the sinus health of patients, is led by co-founder and CEO Thomas A. Schreck. Prior to SinuSys, Mr. Schreck was the founding Chairman and CEO of AcelRx, as well as the founding CEO and President, CFO, and Director of DURECT Corporation. He has also held various investment banking positions in the San Francisco Bay area and London and has raised over $300 million for medical device and biotechnology companies throughout his career.
Mr. Schreck explained: "In the post-FESS patient population, drug-eluting spacers or stents are typically inserted into the surgically revised sinus opening to deliver steroids locally for reduction of inflammation, scarring and adhesions. Traditional spacers or stents are designed to slowly degrade and be bio-absorbed in place, but their polymer scaffolds can degrade unevenly, causing inflammation and requiring surgical removal of remnants and damaged tissue. Our lead product candidate Restora infuses the desired steroid via a bio-inert and non-inflammatory matrix material that is long-proven with exemplary safety profiles in humans, and that is simply and painlessly inserted and then fully removed by the physician after treatment."
Mr. Schreck continued: "We believe that PBI's patented UST platform for the preparation of nanoemulsions is a compelling transformational technology for therapeutics. Its use is expected to require loading less of the active steroid into the Restora device, while optimizing controlled dosing delivery with minimized risk of overdose exposure to the patient. We are excited to work with PBI's outstanding team of scientists and innovators on this opportunity to improve and optimize our lead compound with their next-generation, UST-based nanoemulsion technology, which we believe will enhance the probability for a successful Restora Phase IIb trial later this year."
Dr. Alexander V. Lazarev, PBI's Chief Science Officer, commented: "Our patented UST platform is a unique breakthrough for nanoemulsification processing designed to resolve multiple substantive problems facing manufacturers of therapeutic drugs, nutraceuticals, and other products containing hydrophobic (water repelling) active ingredients that are at best poorly soluble in water. Poor water solubility results in lower absorption rates and requires much higher loading of the active compounds into products to achieve targeted dosing and bioavailability of active ingredients for the patient. Unfortunately, poor water solubility also carries overdosing risks in conventional emulsions due to oil and water phases further separating and leading to non-uniform drug distribution. Scientific publications have demonstrated that hydrophobic active ingredients manufactured into high quality nanoemulsions with droplet sizes of less than 100 nanometers can facilitate increased absorption and bioavailability while lowering doses and improving controlled release. This should result in better quality products and treatment experiences for the patient, with overall reduction in product costs."
In the post-surgical nasal drug delivery markets, two companies that stand out at present are Intersect ENT and Lyra Therapeutics. Intersect is a medical technology company with existing products on the market, including mini drug-releasing implants for patients undergoing sinus surgery to treat chronic sinusitis. Lyra is a clinical-stage company developing drugs and new treatment options targeting ears, nose, and throat ("ENT") conditions.
Mr. Richard T. Schumacher, President & CEO of PBI, provided context on these opportunities: "We believe the therapeutics applications for our uniquely enabling UST nanoemulsions technology platform will be transformational across a wide swath of pharmaceutical, biopharmaceutical, nutraceutical, cosmeceutical, dermatological, medical device, and many other applications and markets. We are at an exciting moment in PBI's development when our new, proprietary UST technology platform is soon to be commercially released (mid to late 2021) and initial collaborations are being both announced and commenced. We have recently been approached by several other companies with therapeutics applications. We anticipate multiple additional collaboration and licensing announcements soon, all of which we believe could add significantly to our revenue in 2021, and beyond."
“Be Fearful When Others Are Greedy and Greedy When Others Are Fearful”
Warren Buffett
Recent PBIO News
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 02/27/2024 06:42:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 10:30:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 09:24:44 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 09:24:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 09:24:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 09:24:34 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 09:24:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 09:24:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:44:21 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 08:18:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/25/2023 09:10:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 02:19:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 02:17:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 02:14:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 02:12:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 02:08:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 02:03:38 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/21/2023 09:26:41 PM
FEATURED Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • Apr 25, 2024 8:52 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM