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The Trendlines Group ORD (TRNGF) is a leading investment firm that focuses on innovative medical technologies and startups. Through its portfolio companies like ZygoFix Ltd. and Ceretrieve, Trendlines has made significant strides in revolutionizing spinal fusion surgery and stroke care, respectively. ZygoFix's zLOCK Lumbar Facet Fixation System, recently FDA cleared, offers a minimally invasive solution for spinal fusion, while Ceretrieve's aspiration catheter boasts impressive results in removing clots in a single pass, thus improving outcomes for stroke patients. Trendlines' commitment to innovation and partnership with cutting-edge companies solidify its position in the medical technology sector.
Arcuro Medical has received FDA 510(k) clearance for its new SuperBall-RC™ system designed for rotator cuff repair procedures. The technology addresses the significant challenge of rotator cuff re-tear rates, which affect 20%-40% of patients over 50 years old. The system builds upon Arcuro's established SuperBall platform, which has been successfully used in over 5,000 meniscus repairs.
The device aims to simplify the fixation of rotator cuff augmentation grafts, offering surgeons an improved solution for enhanced healing outcomes. Following this regulatory milestone, Arcuro plans a user release in Q2 2025, with a full market launch scheduled for the second half of 2025 - ahead of their original timeline due to expedited FDA clearance.
Limaca Medical's Precision-GI™ endoscopic biopsy device has been granted transitional pass-through (TPT) payment by CMS, effective January 1, 2025, for up to three years. The device, which received FDA Breakthrough Device Designation in 2022 and FDA clearance in August 2023, is designed to improve biopsy results for gastrointestinal cancers. The motorized, automated rotating cutting mechanism enables superior tissue acquisition with less blood content in a single pass, enhancing diagnostic efficiency. The TPT program will support broader patient access by providing additional payments to hospitals to cover adoption costs. The device began its U.S. market entry in September 2024.
Vensica Medical has secured an $11 million funding round led by Israel Biotech Fund (IBF), with participation from strategic partners Merz and Laborie. The funding will support Phase 2 clinical trials in the US and Europe for their innovative overactive bladder (OAB) treatment. The company's proprietary technology delivers botulinum toxin A (Xeomin®) through a needle-free device directly to the bladder wall, offering a potentially less invasive alternative to traditional injections. Through its partnership with Merz, Vensica has obtained exclusive rights to Xeomin® for needle-less applications in various urologic indications.
Dasyo, a pioneer in noninvasive medical aesthetics technologies, has appointed Domenic (Dom) Serafino as Executive Board Chair. Serafino brings extensive industry experience, having co-founded and led Venus Concept Inc. to over $100 million in annual revenues. He was also instrumental in Syneron Medical Corp's successful IPO. Dasyo, funded by the Israel Innovation Authority and The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), is developing a groundbreaking non-surgical breast lift product using proprietary technology for noninvasive directional skin tightening. This appointment is expected to significantly enhance Dasyo's strategic direction and growth potential in the aesthetics medical device sector.
Ceretrieve announced successful results of its multicenter, single-arm study for its aspiration catheter, aimed at treating acute ischemic stroke (AIS) caused by large vessel occlusion (LVO).
The study involved 20 patients and achieved 100% Complete/Near-Complete Perfusion with the Gen 2 device, far exceeding the 30%-40% rate of current gold-standard devices.
Ceretrieve's device allows single-pass clot removal and full blood flow restoration, ensuring high safety by minimizing the risk of clot fragments moving further into the brain.
The technology demonstrated superior performance compared to existing devices, highlighting its potential to significantly improve post-stroke patient outcomes.
ZygoFix, a Trendlines portfolio company, has received FDA clearance for its zLOCK Lumbar Facet Fixation System, revolutionizing spinal fusion surgery. The system, backed by strong clinical evidence, offers a minimally invasive procedure with long-term pain reduction benefits. With CE certification and successful clinical utilization, ZygoFix is poised to make a significant impact in the US market.
Arcuro Medical appointed Jamal Rushdy, a seasoned MedTech industry veteran, as its new CEO. Rushdy brings over 28 years of experience in orthopedics and sports medicine. The company aims to enhance patient care with their SuperBall™ technology for meniscus repair. Lee Ranon, the co-founder, transitions to the COO role. The board expresses confidence in Rushdy's leadership for the company's growth.
Fidmi Medical Ltd., based in Israel, has successfully completed a $2.2 million financing round and launched its FDA-cleared low-profile Percutaneous Endoscopic Gastrostomy (PEG) device in the U.S. The financing round included notable investors such as Micro-Tech Co., Ltd. and The Trendlines Group. This innovative gastrostomy device, designed for long-term nutritional support, targets a market worth $800 million. Its replaceable inner tube and stable internal bumper aim to reduce complications and healthcare costs, enhancing patient quality of life.
Vessi Medical has completed its first-in-human procedure using its cryoablation solution for non-muscle invasive bladder cancer (NMIBC) at Rambam Healthcare Campus, Israel. The procedure was successful, demonstrating ease of use and no complications, with the patient reporting no pain post-discharge. This marks a significant step towards regulatory approval for Vessi's minimally invasive treatment, which aims to improve patient quality of life compared to traditional surgical options.
ZygoFix has received the CE mark for its innovative zLOCK Spinal Fusion System designed for chronic back pain treatment. This minimally invasive system utilizes a screwless design, enhancing safety and reducing surgical invasiveness with only two incisions needed compared to traditional methods. The zLOCK system has been in clinical use in Hungary and Israel for over three years, demonstrating high satisfaction among patients and physicians. ZygoFix also secured ISO13485 certification and plans to conduct a pivotal study in the EU to gather more clinical data.