RefleXion Receives FDA Clearance for SCINTIX Therapy

Congratulations to portfolio company RefleXion Medical on receiving FDA clearance of its SCINTIX™ biology-guided radiotherapy! SCINTIX technology is a novel therapy for patients with tumors in the lung or bone arising from primary or metastatic disease. Read the press release to learn how, for the first time ever, the cancer itself directs treatment via a live stream of PET emissions data that continuously communicates with the linear accelerator.

This Startup Wants to Get in Your Ears and Watch Your Brain

Born from Alphabet’s “moonshot” division, NextSense aims to sell earbuds that can collect heaps of neural data—and uncover the mysteries of gray matter.

Vori Health Transforms Back And Joint Pain Treatment

Neurosurgeon Dr. Ryan Grant and Orthopedic Surgeon Dr. Mary O’Connor want to transform musculoskeletal care by doing less surgery. They are building a multi-billion dollar health service company. Dr. O’Connor is the previous Chair of Orthopedics at Mayo Clinic in Florida and Dr. Grant’s track record as a successful serial entrepreneur means that Vori Health will have a major impact in the musculoskeletal market that affects up to 50% of adults throughout the world.

When a patient sees a surgeon for a consultation there is a strong chance they will end up going under the knife. Studies have raised questions about how effective spinal surgery is for back pain. In many cases, similar or better results can be achieved using options including multidisciplinary care that includes an expert nonoperative physician, physical therapy and lifestyle interventions.

About 100 million adults in the US are affected by chronic pain, including joint pain or arthritis. This leads to 500,000 Americans undergoing surgery each year for low back problems alone. According to the Agency for Healthcare Research and Quality (AHRQ), we spend more than $90 billion each year to relieve back pain, and for the majority, symptoms cannot be attributed to a specific disease or spinal pathology.

Alcon to Acquire Ivantis, Inc. and its Hydrus Microstent for Surgical Glaucoma, Strengthening Global Ophthalmology Portfolio

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced its intention to acquire Ivantis®, developer and manufacturer of the novel Hydrus® Microstent, a minimally-invasive glaucoma surgery (MIGS) device designed to lower intraocular pressure for open-angle glaucoma patients in connection with cataract surgery*. The intended acquisition affirms Alcon’s commitment to the surgical glaucoma space, further strengthening its industry-leading portfolio across cataract, refractive, retina and glaucoma.

The five-year HORIZON clinical study of Hydrus Microstent is the longest, continuous follow-up of a MIGS device. It demonstrated that 65% of Hydrus Microstent patients remained medication-free at five years post-implant. The results also showed over 60% reduction in risk of invasive secondary glaucoma surgeries compared to cataract surgery alone – and its safety profile was sustained through the five-year follow up. Among MIGS rated in the 2020 American Academy of Ophthalmology Primary Open-Angle Glaucoma Preferred Practice Pattern (PPP), the Hydrus Microstent received the highest grade for quality body of evidence and a strong recommendation.

“Glaucoma is the second-largest cause of blindness after cataracts, impacting more than 75 million people globally, with significant unmet patient need. This transaction will allow us to add a uniquely effective product into our glaucoma portfolio around the world,” said David Endicott, CEO of Alcon. “Our global commercial footprint and development capabilities make us well positioned to build on the success of Ivantis and help even more patients see brilliantly with Hydrus Microstent.”

“With more than 85,000 Hydrus devices implanted, now is the time to expand access globally, and Alcon is the right partner as the global leader in eye care,” said Dave Van Meter, President and CEO of Ivantis. “We started this with a mission to bring unprecedented scientific rigor to the MIGS space, and we are gratified and humbled by the rapid adoption of Hydrus since our launch in late 2018. Thanks to the relentless, unwavering commitment of Ivantis employees and our investors, we now have the opportunity to bring the clinically proven Hydrus technology to more glaucoma patients worldwide.”

First U.S. Patient Enrolled in Cardionomic’s CPNS Pilot Study

Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce initial U.S. enrollment in their global Cardiac Pulmonary Nerve Stimulation (CPNS) Pilot Study (NCT04814134). The study is evaluating the safety and performance of the CPNS System in patients suffering from acute decompensated heart failure (ADHF), defined as new or worsening symptoms of heart failure. The first U.S. patient was enrolled and implanted at The Ohio State University Wexner Medical Center in Columbus, OH by Principal Investigator, Dr. Sitaramesh Emani, assisted by Dr. Rami Kahwash.

The CPNS System is founded on the principle that heart failure is a complex syndrome that develops from poor blood flow, and that stimulation of the cardiac autonomic nerves holds the potential to improve flow. The System is comprised of a bedside stimulation console and a catheter that delivers targeted stimulation to the cardiac autonomic nerves from the pulmonary artery. Early studies have demonstrated that the System increases cardiac contractility without significantly changing the heart rate in heart failure patients with reduced ejection fraction.

“For decades, current treatments have failed to prevent hospital readmissions, morbidity, and mortality. CPNS is intended to address these shortcomings and transform care by breaking the cycle of worsening heart failure. Achieving the first U.S. enrollment, as part of our global pilot study, is a significant milestone toward demonstrating Cardionomic’s CPNS as a meaningful treatment for the underserved ADHF patient population,” said Steve Goedeke, CEO & President, Cardionomic, Inc. 

Recovery Centers of America (RCA) Partners with Owl to Deliver Highly Optimized Clinical Treatment for Patients with Substance Use Disorders

Today, Owl announced that Recovery Centers of America (RCA), a leading national provider of evidence-based addiction treatment, has selected Owl’s measurement-based care (MBC) platform to enable enhanced care and measurable clinical outcomes for RCA patients. RCA will implement Owl across its ten inpatient substance use disorder treatment facilities in six states, many of which have been ranked among the top-rated treatment programs in the U.S. according to Newsweek Magazine.

With a mission of helping one million patients achieve a life of recovery by providing alcohol and drug addiction treatment, RCA was drawn to Owl’s innovative measurement-based care solution to efficiently and effectively monitor patient progress throughout treatment. Owl’s comprehensive library of 250+ evidence-based measures will provide RCA with the ability to collect extensive, meaningful data and monitor patients across a breadth of behavioral health conditions.

Owl will enhance RCA’s ability to identify patient-specific needs and create opportunities for effective individualized intervention as well as population-level data to continually assess and improve treatments. Owl will assist RCA with achieving The Joint Commission accreditation standard for best practices in measurement-based care.

“Owl will assist RCA with the delivery of a breadth of evidence-based measures and actionable data that is both patient-friendly and burden-free for clinicians,” said Kerry King, Vice President of Clinical Services, Recovery Centers of America.