Esophageal Achalasia

Phase II/III clinical trial to initiate enrollment in Q4 2023 TEMPE, Ariz.--(BUSINESS WIRE)-- Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm. Nectero Medical is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness with first subject enrollment targeted in Q4 2023. Breakthrough Therapy designation is an FDA program intended to facilitate design and conduct of an efficient product development program. It is a challenging status to obtain. Designation requires that the novel drug treats a serious condition, and preliminary clinical evidence indicates that the drug may provide a substantial improvement over available therapy on a clinically significant endpoint(s). Nectero Medical’s Breakthrough Therapy designation is supported by results from the first-in-human (FIH) study (NCT05133492) of the Nectero EAST System. Early clinical results of the FIH study were recently published in the Journal of Vascular Surgery and showed that a single, localized PGG administration to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAAs. Additional follow-up data will be presented at the VEITH Symposium in New York later this year. In addition to the benefits of Fast Track (received in August 2023), which allows for more frequent FDA interactions and eligibility for priority and rolling review, Breakthrough Designation adds FDA’s organizational commitment to involve senior managers. Nectero Medical will meet with the Agency near term to review the development program and establish a plan for ongoing communications. AAA is a serious condition associated with the potential for rupture and sudden death. The Nectero EAST System is intended to treat early, in small to mid-size aneurysms, and potentially avoid the need for a future, more invasive procedure that carries greater risks of morbidity and mortality. “This designation reinforces Nectero Medical’s belief that the Nectero EAST System has the potential to have a significant impact for patients with AAA disease,” said Jack Springer, President and Chief Executive Officer of Nectero Medical. “We look forward to working closely with the FDA to advance this product to patients as quickly and efficiently as possible.” About the Nectero EAST® System The Nectero EAST System is a single-use, endovascular system for the treatment of infrarenal abdominal aortic aneurysms (AAA). It is estimated that >1M Americans are living with AAA and ~60,000 undergo treatment each year; complications of AAA account for approximately 10,000 deaths in the U.S. annually. Available treatments are primarily reserved for AAAs larger than 5.0/5.5cm (female/male) in diameter, symptomatic patients, or rapidly expanding aneurysms. Smaller AAAs are traditionally monitored with serial ultrasound or CT surveillance. Patients with small- and mid-sized aneurysms carry a .5-5% annual risk of rupture. The Nectero EAST System is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation. The procedure does not require any specialized tools, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. If successful, the Nectero EAST System may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance. For more information, please visit necteromedical.com. CAUTION: There is no assurance as to the results of the study described in this press release or the efficacy of the Nectero EAST System.

Minimally invasive endoscopic procedure offers treatment to patients with esophageal motility disorders SAVANNAH, Ga., Oct. 31, 2023 /PRNewswire/ -- A United Digestive physician has successfully completed the first Peroral Endoscopic Myotomy (POEM) procedure in Savannah, Ga. Daniel K. Mullady, MD, a leading expert in gastroenterology and interventional endoscopy at Center for Digestive and Liver Health (CDLH), has achieved this significant milestone, marking a groundbreaking moment for the local medical community and patients in need of advanced esophageal treatments. Continue Reading Daniel K. Mullady, MD POEM is a minimally endoscopic technique used to treat esophageal motility disorders, particularly achalasia. This innovative procedure involves making a small incision in the esophagus and using endoscopic tools to access and cut the muscles causing constriction, allowing for improved swallowing and digestion. The procedure offers hope for individuals suffering from esophageal motility disorders, and has comparable results to surgery, which has been the traditional treatment for this condition. CDLH has been the premier GI group in Savannah for more than 30 years and continues to offer the best gastroenterology care in Savannah and the surrounding communities. Dr. Mullady has broad experience in Interventional Endoscopy and has performed numerous complex procedures throughout his 15-year career. He joined CDLH in 2022 and is committed to advancing interventional endoscopy in the Savannah area. "I am honored to have performed the first POEM procedure in the Savannah area. This technique allows us to provide our patients with less invasive treatment options than surgery for complex esophageal conditions," Dr. Mullady said. "We are committed to continuing our mission of delivering the highest level of care and innovation to our community." About United Digestive United Digestive is a leading physician practice management organization serving GI physicians and gastroenterology practices nationwide. Practices that are part of United Digestive benefit from advanced infrastructure and operational insights, along with investments in regional growth. Physician Partners enjoy a dyad leadership model with reduced administrative burden and local support to provide the highest-quality patient care. United Digestive is growing at a rapid pace, with more than 62 clinics, 22 ASCs, and 300 providers practicing in four states – Georgia, Florida, North Carolina, and South Carolina. Lance Wagner [email protected] SOURCE United Digestive

WILMINGTON, N.C., Oct. 17, 2023 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today welcomed the recent announcement by Nectero Medical that they have received clearance from the U.S. Food and Drug Administration of their IND application to initiate Phase II/III trial of the Nectero Endovascular Aneurysm Stabilization Treatment (EAST®) System for the treatment of small- to-mid-sized abdominal aortic aneurysms (AAA). Nectero Medical is developing a novel treatment to stabilize growth and potentially prevent rupture of smaller AAA. The Nectero EAST System is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation. Early Phase I clinical results on the initial 20 patients treated outside of the U.S. were recently published in the Journal of Vascular Surgery and showed that a single, localized PGG administration to patients with small- to mid-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAAs. "We congratulate Nectero Medical on their recent IND clearance and proudly support the work they are doing to address a significant unmet clinical need and improve outcomes in AAA patients," commented Jamie Iudica, Chief Manufacturing Officer of Alcami. Alcami's support of Nectero Medical's drug/device combination product has consisted of accelerated analytical method and process development activities and sterile drug product cGMP manufacturing in support of clinical studies." The integrated service we have provided is a testament to our technical depth, modern capabilities, and relentless focus on the success of our customers," added Mr. Iudica. "We thank the Alcami team for their continued support of the important work we are doing," commented Jack Springer, President and Chief Executive Officer of Nectero Medical. "Nectero Medical is addressing the over 1,000,000 patients in the US with an AAA and currently no method of treatment. Alcami was able to move quickly and provide high-quality deliverables in support of our past and ongoing projects." Established over 40 years ago, Alcami has evolved into one of the industry's premier drug product development and manufacturing partners. Alcami offers six sterile filling suites for injectables. With co-located early development, pre-formulation capabilities, and redundant laboratory and manufacturing network, Alcami is well positioned to support oral solids and sterile drug product programs from clinical scale to commercial supply. Nectero EAST® is a registered trademark of Nectero Medical. About Alcami Corporation Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Alcami serves pharmaceutical and biotech companies of all sizes for small molecules and biologics, providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid dose drug product manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami's private equity ownership includes GHO Capital, The Vistria Group, and Ampersand Capital Partners. For more information, please visit alcaminow.com. SOURCE Alcami Corporation