Diabetic Neuropathies

Milestone Achievement Supports Planned FDA Submission of DeepView AI®-Burn in 2025 DALLAS, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the final group of burn center patients in the Company’s U.S. Burn Pivotal Study have successfully completed their clinical visits. One of the largest domestic burn center studies ever conducted, the U.S. Burn Pivotal Study is expected to be the final clinical trial before the Company seeks U.S. Food and Drug Administration (“FDA”) approval of its DeepView® System for burn indication (“DeepView AI®-Burn”) in the first half of 2025. DeepView AI®-Burn is a non-invasive, predictive medical device designed to distinguish between healing and non-healing tissue in order to provide clinicians with an immediate and binary assessment of a burn wound’s healing potential. The Company expects to report topline results from this study in December 2024. “The completion of this aspect of the U.S. Burn Pivotal Study marks a critical milestone on our path towards commercialization,” said Dr. J. Michael DiMaio, Chairman of the Board. “These results will form the foundation of our forthcoming U.S. regulatory submission and brings us one step closer to delivering a potentially groundbreaking advancement in burn wound assessment that can support clinical decision-making regarding next step treatment plans, broaden equity in access to burn care treatment, and improve clinical outcomes. I want to thank our investigators, their dedicated staff, and study enrollees for their support in this endeavor.” About the U.S. Burn Pivotal Study The U.S. Burn Pivotal Study was initiated in January 2024 and involves 160 adult and pediatric patients at 14 burn centers across the country. It is designed to validate the AI-driven closed loop algorithm used by DeepView AI®-Burn. Each patient underwent non-invasive imaging of their wound using DeepView AI®-Burn beginning at the initial clinical assessment and until the treatment plan was defined. An end image was required at 21 days following initial assessment. About Spectral AI Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView™ System. The DeepView™ System is a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to change the current standard of care, the DeepView™ System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView™ System, visit www.spectral-ai.com. Forward Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Investors: The Equity Group Devin Sullivan Managing Director dsullivan@equityny.com Conor Rodriguez Analyst crodriguez@equityny.com

Boston biotech Axonis Therapeutics has raised a $115 million Series A to test whether its oral drug AXN-027 can help patients with focal epilepsy and diabetic neuropathic pain. The financing, disclosed Wednesday morning, will get the biotech into the clinic around the end of this year, or about the same time Ovid Therapeutics expects to begin human trials with a similar approach by way of an AstraZeneca platform it licensed. Both companies are looking at KCC2, a CNS chloride transporter that is key to electrical signaling in the brain. KCC2 allows for neuronal GABA signaling. The GABA pathway has been targeted by multiple drugmakers , including Sage’s postpartum depression medicine Zurzuvae , but biotechs have yet to enter the clinic with a focus on KCC2, CEO Joanna Stanicka told Endpoints News . “Often GABA treatments can induce global inhibition, which leads to this cognitive impairment and sedation often reported by patients,” Stanicka said, adding that focused inhibition should avoid those side effects. The 13-employee biotech also said Wednesday that it added Donald Manning as chief medical officer and Jeff Imbaro as operating chief. Manning previously held the same post at Travecta, Pacira BioSciences and Adynxx. Imbaro was in the same role at stroke-focused Elevian, and before that he was a founding member of Vertex-acquired Semma Therapeutics. Axonis was founded by spinal cord injury patient advocate and board observer Bob Yant about 15 years ago, but it didn’t become “operational” until 2019, Stanicka said. Prior to the Series A, Axonis had raised about $34 million in seed funding and about $9 million in government and foundation money, Stanicka said. Its investors include Cormorant Asset Management, venBio, Sofinnova Investments, Merck’s corporate venture arm and others. The startup anticipates the Series A will fund AXN-027 through Phase 2 proof-of-concept studies, she said.

Analysis Marks the First Study of Spinal Cord Stimulation to Demonstrate Long-term, Significant, and Clinically Meaningful Reductions in HbA1c and Weight in Study Participants with Painful Diabetic Neuropathy and Type 2 Diabetes REDWOOD CITY, Calif., Oct. 29, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of new data in the Journal of Pain Research demonstrating significant, durable pain relief and long-term and clinically meaningful reductions in hemoglobin A1c (HbA1c) and weight in study participants with painful diabetic neuropathy (PDN) and Type 2 diabetes who received 10 kHz high-frequency spinal cord stimulation (SCS) therapy.1 Globally, the number of people with diabetes has quadrupled in the last two decades2, and PDN impacts up to 25% of all people with diabetes.3 PDN can have significant impacts on the quality of life for people living with this condition, with symptoms like numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.4 Patients typically manage PDN with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects.5 As a result, people with PDN suffer from significantly reduced health-related quality of life (HRQoL), impaired functionality and other comorbidities like sleep disorders, depression, and anxiety.6 The analysis evaluated 144 patients with Type 2 diabetes and refractory PDN who received 10 kHz SCS therapy during the SENZA-PDN randomized controlled trial (RCT), the largest RCT to evaluate SCS to treat PDN. Changes in pain intensity, HbA1c, weight, and sleep were evaluated over 24 months, with participants stratified according to preimplantation HbA1c. At 24 months, the following benefits were noted1: Significant, durable pain relief: Study participants had a mean pain reduction of 79.8% and the mean visual analog scale (VAS) score for lower limb pain decreased from 7.5 ± 0.1 cm at preimplantation to 1.5 ± 0.2 cm (p < 0.001). Clinically meaningful, statistically significant mean reductions in HbA1c: Participants with preimplantation HbA1c >7% and >8% achieved mean reductions of 0.5% (p = 0.031) and 1.1% (p = 0.004), respectively. Significant mean weight loss: Across all study participants, patients achieved a significant mean weight loss of 3.1 kg (p = 0.003). In participant subgroups with body mass indices (BMI) of ≥ 30 and ≥ 35 kg/m2, mean weight reductions were 4.1 kg (p = 0.001) and 5.4 kg (p = 0.005), respectively. Significant, durable reductions in pain interference with sleep: Study participants experienced a highly significant improvement in sleep quality, with pain and sleep questionnaire three-item (PSQ-3) scores decreasing by a mean of 65.2%, corresponding to a mean value of 1.9 ± 0.2 cm (p < 0.001). "People with PDN know that this condition can extend well beyond pain – impacting sleep, sensory functions, and overall quality of life," said Dr. David Klonoff, Medical Director, Diabetes Research Institute at Mills-Peninsula Medical Center. "This is the first study of SCS to demonstrate long-term, significant and clinically meaningful reductions in HbA1c and weight in people with PDN and Type 2 diabetes – suggesting possible metabolic benefits with 10 kHz SCS for these patients." "The SENZA-PDN RCT has already demonstrated the significant pain relief benefit when using Nevro's HFX device for the millions of people suffering from PDN around the world," said Dr. David Caraway, Nevro's Chief Medical Officer. "Now, for the first time, we've observed secondary benefits like improved HbA1c and weight loss, which exhibit potentially disease-modifying effects for people with Type 2 diabetes. I'm grateful for the dedication of the clinical investigators who supported this latest analysis and the broader SENZA-PDN RCT as we continue gathering data to support market access for more patients." The 24-month data from the SENZA-PDN RCT were originally published in Diabetes Research and Clinical Practice in 2023. These data showed that patients who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM), compared to CMM alone, experienced durable pain relief and improvements in HRQoL, neurological function, and sleep at 24 months post-implantation. To learn more about Nevro's 10 kHz Therapy™ for PDN, visit . References Nevro's high-frequency, 10 kHz spinal cord stimulation (SCS) device has not been approved or evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of HbA1c and/or weight loss. World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. Shillo P, et al. Painful and Painless Diabetic Neuropathies: What Is the Difference? Curr Diab Rep. 2019 May 7;19(6):32. doi: 10.1007/s11892-019-1150-5. PMID: 31065863; PMCID: PMC6505492. Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association; 2022. Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain medicine (Malden, Mass.), 16(11), 2075–2083. Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes research and clinical practice, 109(2), 215–225. Internet Posting of Information Nevro routinely posts information that may be important to investors in the "Investors" section of its website at . The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro. About Nevro Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 115,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy. Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients. Senza®, Senza II®, Senza Omnia™, and HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with Nevrocloud™ insights for enhanced patient and practice management. SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, Nevrocloud, RELIEF MULTIPLIED, HFX AdaptivAI, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents. Bluetooth® and the Bluetooth symbol are registered trademarks of their respective owners. To learn more about Nevro, connect with us on LinkedIn, X, Facebook, and Instagram. Investors and Media: Angie McCabe Vice President, Investor Relations & Corporate Communications [email protected] SOURCE Nevro Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED