PHARMA TECH

Aidoc and Subtle Medical Partner to Bring End-to-End AI Solutions to Medical Imaging

Aidoc | September 15, 2021

Aidoc, leading provider of AI for medical imaging, announced today a partnership with Subtle Medical, developer of leading AI-based image enhancement bringing best-of-breed AI to both image acquisition and post-acquisition clinical workflows. Aidoc has developed the industry's most robust AI platform, delivering a unified and seamless cross-specialty AI experience for physicians in over 500 medical centers, including the largest clinical deployment of AI in healthcare at Radiology Partners.

"Mainstream healthcare adoption of AI requires both a comprehensive package of premier AI solutions and an ability to deliver their results in a reliable and seamless manner across physician workflow, Through this partnership, we will provide health systems and imaging centers with Subtle Medical's optimal solution, now seamlessly delivered through a unified AI architecture. Our platform's ability to deliver interoperable AI solutions is a game changer for AI adoption."

- Tom Valent, VP of Business Development at Aidoc.

A pioneer in healthcare AI, Aidoc's FDA-cleared solutions analyze medical images for critical conditions and trigger actionable alerts directly in the imaging workflow supporting medical specialists in reducing turnaround time and improving quality of care.  Subtle Medical's AI-powered software solutions, SubtlePET™ and SubtleMR™ are image enhancement tools that increase the efficiency of image capture by improving the quality of accelerated scans. This enables optimized scan times and can potentially increase the number of patients scanned per day. Subtle's solutions are compatible with all scanner brands, models and field strengths so institutions can see the benefit across their entire scanner fleet.

"This agreement will provide our customers with a multimodality solution that includes acquisition workflow efficiencies and image quality improvements together with Aidoc's post-acquisition clinical workflow solutions, We believe that the integration of Subtle's AI-based software tools with the Aidoc platform will dramatically change the medical imaging equation."

- Josh Gurewitz, Chief Commercial Officer at Subtle Medical. 


About Subtle Medical
Subtle Medical, Inc. is a leading healthcare technology company making medical imaging faster, safer, and smarter. For more information, visit subtlemedical.com.

About Aidoc
Aidoc is the leading provider of artificial intelligence solutions that support and enhance the impact of physician diagnostic power - helping them expedite patient treatment and improve quality of care.

Spotlight

You may have designed the most incredible new medical device with the potential to improve health outcomes in markets around the world, but without getting the right manufacturing strategy in place – it may never see the light of day. How you decide to manufacture your device, whether that’s in your own factory or outsourced to a contract manufacturer is a critical decision in terms of cost.

Spotlight

You may have designed the most incredible new medical device with the potential to improve health outcomes in markets around the world, but without getting the right manufacturing strategy in place – it may never see the light of day. How you decide to manufacture your device, whether that’s in your own factory or outsourced to a contract manufacturer is a critical decision in terms of cost.

Related News

PHARMA TECH

MyMD Pharmaceuticals Announces Issuance of U.S. Patent Covering Lead Drug Candidate MYMD-1 in a Method of Extending Lifespan

MyMD | November 24, 2021

MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent 11,179,382 B2, titled “Methods of Reversing Normal Aging Process and Extending Lifespan.” The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual. “This patent is a timely addition to our IP portfolio as we advance toward the launch of our fully funded Phase 2 trial of MYMD-1 for aging. After a comprehensive review by USPTO, we are pleased with the broad scope of the granted claims which offer further protection for our lead drug candidate, which we believe has the potential to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging healthy lifespan,” Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD “Our primary focus for MYMD-1 is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan,” Dr. Chapman added. “It’s also important to note that MYMD-1 shows promise in pre-clinical studies as a treatment for immune diseases including rheumatoid arthritis, multiple sclerosis, and Hashimoto’s thyroiditis, and as an anti-fibrotic and anti-proliferation therapeutic.” The latest patent adds to MyMD’s intellectual property portfolio of 14 granted patents (12 U.S. and two foreign) covering MYMD-1 in methods of treating chronic inflammation, autoimmune disorders, diabetes, multiple sclerosis, viral infections, addictions, fibrosis, asthma, and other disorders. MyMD also holds two patents for its synthetic cannabidiol (CBD) derivative Supera-CBD. An additional 30 patent applications are pending worldwide. About MYMD-1 Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic. MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. About MyMD Pharmaceuticals, Inc. MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.

Read More

PHARMACY MARKET

LIDDS Next Step with NanoZolid® formulated docetaxel

LIDDS AB | February 22, 2022

LIDDS AB announced that the next step in the development of NanoZolid®-formulated docetaxel will be to conduct a short clinical study to understand the immunological effects observed in the Phase I clinical study NZ-DTX-001. In the NZ DTX-001 study, activation of systemic inflammatory biomarkers was observed, which can provide improved conditions for treatment with so-called checkpoint inhibitors and result in treatment effect in non-injected tumors. In the clinical phase I study with nanodotax, which ended in October 2021, an activation of systemic inflammatory biomarkers was observed, which may open up the possibility of a combination therapy with so-called checkpoint inhibitors in cancer immunotherapy. Clinical studies have shown that systemically administered docetaxel significantly improves the response to treatment with checkpoint inhibitors. If LIDDS can show a similar effect with locally administered nanodotax but without systemic side effects, which risk inhibiting the specific immune response against the tumors, both improved efficacy and safety could be achieved. LIDDS has shown in preclinical studies that locally administered nanodotax has as good effect as systemically administered docetaxel but without systemic side effects. In order to provide a better foundation for decision-making in the clinical development of nanodotax, LIDDS has chosen to take over the sponsorship of the previously approved investigator driven trial on prostate cancer patients. The study provides an important analysis opportunity of the immunological response as the included patients will have their prostate surgically removed, which can be analyzed in detail. The study is planned to be conducted at one clinical site and is expected to include ten patients. “Based on the exciting activation of immunoregulatory molecules we saw in the Phase I study, it is important to confirm the mechanism of action of nanodotax. The increased understanding of the mechanism will more promptly lead us to the right form of treatment and patient group. The results may possibly also pave the way for more effective combination treatments, which is considered crucial for the commercial positioning of nanodotax and it justifies a further study” Nina Herne, CEO of LIDDS In December 2021, LIDDS announced the top-line data of the clinical Phase I study NZ-DTX-001. It was demonstrated that NanoZolid® in combination with docetaxel was safe and well tolerated, reaching the primary endpoint of the trial. The data also showed that the systemic docetaxel exposure was low and that activity in injected lesions was observed. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors. The information was submitted for publication, through the agency of the aforementioned contact person, on February 21, 2022 at 16.30 CET. LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS.

Read More

PHARMACY MARKET

Antares Pharma Announces FDA Acceptance of NDA Resubmission for TLANDO®

Antares Pharma, Inc. | February 04, 2022

Antares Pharma, Inc. a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO®, an oral treatment for testosterone replacement therapy. The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act. TLANDO® was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022. “As we take this final step moving from tentative approval to potential final approval in late March, we will continue to prepare for the commercial launch of TLANDO. Our National Sales Meeting is set for the end of April and will serve as the venue to train and ready our sales professionals to start promoting TLANDO to the medical professionals who treat testosterone deficiency. We are excited to be able to complement our current offering of XYOSTED with an oral formulation to patients and physicians. We will leverage our strong physician relationships which we believe will accelerate the adoption of TLANDO, support our future revenue growth and drive our market share gains in the testosterone market,” Robert F. Apple, President and Chief Executive Officer of Antares Pharma About Antares Pharma Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® in the U.S. and expects to commercially launch TLANDO® in the U.S. pending final FDA approval.

Read More