Limaca Medical News
9 articlesLimaca Medical Ltd. ("Limaca") has launched its Precision-GI™ endoscopic automated motorized EUS biopsy device in the US market....
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Limaca's Precision-GI™ Granted CMS Transitional Pass-Through (TPT) Payment
Limaca Medical Ltd. has received a transitional pass-through (TPT) payment approval from the Centers for Medicare & Medicaid Services (CMS) for its Precision-GI™ motorized endoscopic biopsy device. This approval, effective from January 1, 2025, will enhance patient access to this innovative technology, which has already been granted FDA clearance and Breakthrough Device Designation. The Precision-GI™ device offers improved biopsy results for gastrointestinal cancers, reducing the need for repeat procedures. Limacas U.S. market entry commenced in September 2024, and the company is also pursuing market entry in Japan with its partner HekaBio. Limaca is funded by several investors, including the Israeli Innovation Authority and The Trendlines Group.
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Limaca Medical Completes 24 EUS Pancreatic and Liver Biopsy Cases
Limaca Medical has announced the successful completion of twenty-four cases using its Precision-GI™ endoscopic ultrasound guided motorized fine needle biopsy (EUS-mFNB) device. The device, which has received FDA Clearance and Breakthrough Device Designation, demonstrated significant tissue acquisition. The ongoing study, led by Dr. Carlos Robles-Medranda, shows that Precision-GI is quickly and efficiently obtaining contiguous intact core tissue samples for definitive diagnosis of target tissues. The device is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more efficiently and less traumatically than current products.
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FDA Grants Breakthrough Designation to Endoscopic Biopsy Device
Limaca Medicals Precision-GI Endoscopic Ultrasound Biopsy Product has received Breakthrough Device Designation from the FDA. The device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract, providing more efficient and effective diagnosis of GI cancers. The FDA designation will accelerate the progress toward obtaining FDA clearance for the product. Limaca Medical is primarily funded by the Israeli Innovation Authority, Agriline, and The Trendlines Group Ltd.
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Limaca Medical and HekaBio Announce Japan Partnership
Limaca Medical has entered into a strategic partnership agreement with HekaBio K.K. to distribute Limacas Precision-GI™ Endoscopic Biopsy Device in Japan. The partnership aims to advance precision medicine and improve endoscopic biopsy results for patients facing gastroenterology cancers. HekaBio will provide operational support, logistics, physician training, and case support in Japan. The partnership is expected to have a positive impact on Limacas growth. Limaca recently received FDAs Breakthrough Device Designation for Precision-GI. Limaca Medical is based in Israel and has a team of engineers, clinicians, and business professionals dedicated to developing and commercializing specialized medical devices. The companys investors include The Trendlines Group, Ltd and Agriline.
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Limaca Medical Receives FDA Breakthrough Device Designation
Limaca Medicals Precision-GI Endoscopic Biopsy Device has received a Breakthrough Device Designation from the U.S. FDA. The device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract, providing more efficient and effective diagnosis of GI cancers. The automated design aims to yield superior quality and quantity of biopsy tissue. The FDAs designation expedites the devices development and evaluation. Limaca Medical is dedicated to improving endoscopic biopsy results for patients facing gastroenterology cancers.
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Drilling tissue for biopsies, startup eyes better tumor samples
Israeli startup Limaca Medical has developed a medical device for endoscopic ultrasound-guided biopsies that offers greater procedural efficiency and less trauma. The device, called Precision, uses an automated revolving needle to extract tissue samples with just two or three stabs, resulting in high-quality samples for analysis. Limaca has raised $1.25 million in funding from investors including The Trendlines Group Ltd., Agriline, and Limacas chairman Carl Rickenbaugh. The company is currently conducting clinical trials and plans to expand the trial to other medical centers and initiate new trials in Europe and the US. Limaca aims to commercialize the product in 2022 and initially target biopsy sampling for pancreatic cancer.
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Limaca Medical Raises $1.25 Million to Enhance Precision Medicine Through Improved Biopsies
Limaca Medical, a portfolio company of The Trendlines Group, has closed $1.25 million of a $1.5 million funding round. The funding will be used to complete first-in-human procedures, post-market clinical studies, and obtain regulatory approvals for Limacas Precision biopsy device. The device aims to improve upon endoscopic biopsies and provide better diagnostic accuracy and patient-specific treatment for cancer patients. Limaca has enrolled 10 patients in its first-in-human study, comparing Precision to standard of care EUS biopsy devices. The initial market for Precision is biopsy sampling for pancreatic cancer, with additional markets for lung cancer, liver biopsy, lymphoma, and other cancers. The funding round included investments from Trendlines, Agriline, Limacas Chairman Carl Rickenbaugh, and a private investor.
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Limaca Medical Initiates First-in-Human Study of Biopsy Device for Improved Tumor Diagnosis
Limaca Medical Ltd., a portfolio company of The Trendlines Group Ltd., has announced the start of its first-in-human clinical study for its electromechanically driven Endoscopic Ultrasound-guided biopsy device. The study aims to assess safety and performance. Limacas KORA GI, the biopsy device, is less operator dependent and yields better results compared to manually-driven devices. The company is pleased with the start of the study and hopes to provide the market with an improved biopsy product. Limaca has also launched a $2 million financing round to support its FDA 510(k) submission and CE mark clearance, production scale-up, and U.S. Registry Study.
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