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Caesarea, Israel, June 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” or the “Company”), minimally invasive cryotherapy (“IceCure (Shanghai) MedTech Co. ., Ltd. (“IceCure”, a wholly owned subsidiary of IceCure (Shanghai ) MedTech Co., Ltd. Shanghai”), signed a contract to build the IceSense3 cryoablation system with Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), a subsidiary of Medtronic Corporation (NYSE: MDT) (“Medtronic”) and Beijing Turing Medical Technology Co., Ltd. (“Turing”) The first IceSense3 systems are expected to be delivered in 2022.
Medtronic Shanghai will become the sole distributor of IceSense3 and its disposable probes in mainland China for an initial three-year period, with a minimum purchase target of $3.5 million during this period. In addition, in mainland China, Shanghai Medtronic will not directly or indirectly invest in or trade, sell, market, promote or offer any product that competes with IceSense3 during the term of the distribution agreement and beyond six (6) months. Turing will be responsible for the import, installation and after-sales service of the IceSense3 system in mainland China, while Medtronic Shanghai will handle all marketing, sales and certain professional training.
The IceSense3 System Console is approved by the China National Medical Products Administration (“NMPA”). IceCure has applied for a registration certificate change to approve disposable probes that, if approved, would allow the company to market its IceSense3 disposable cryoprobes for commercial use, and IceCure expects to receive NMPA approval for the probes by the end of 2022.
“Shanghai Medtronic and Turing are ideal partners for us in mainland China, where market penetration of cryoablation technology is currently low. We see an excellent opportunity for the widespread adoption of our IceSense3 cryoablation system in mainland China, a market that is growing very rapidly. that improve results,” said IceCure CEO Eyal Shamir. “As part of the world’s largest medical device company, Shanghai Medtronic has the experience and market power to enable rapid market penetration of IceSense3 to provide safe, effective and cost-effective treatment for early breast cancer and other indications.”
“IceCure has the world’s leading tumor cryoablation solution,” said Jing Yu, vice president and general manager of Skull, Spine and Orthopedic Technologies at Medtronic Shanghai. The partnership with IceCure and Turing Medical will complement Medtronic Shanghai’s product line in oncology neurosurgery. We hope that this collaboration will advance the clinical application of cryoablation and benefit more tumor patients, and we also look forward to working with more partners to accelerate the adoption and deployment of advanced medical solutions that will help solve key tumor treatment challenges. Health Sector of China.
Turing CEO Lin Youjia added, “In partnership with Shanghai Medtronic and IceCure, we are committed to starting the deployment and rapid installation of the IceSense3 system in mainland China. Our nationwide presence in mainland China ensures that medical centers receive superior technical support and service has been using their IceSense3 system for a long time.”
On June 12, 2022 (“Effective Date”), IceCure Shanghai entered into an exclusive sales and distribution agreement (“Distribution Agreement”) with Shanghai Medtronic and Turing for IceSense3 and disposable probes (“Products”) for an initial period. 36 months, the minimum purchase objective for this period is $3.5 million (“Minimum Purchase Target”). Under the distribution agreement, IceCure Shanghai will sell Turing products and Turing will import products from Israel to mainland China and then resell them to Medtronic Shanghai. Medtronic Shanghai will be responsible for, among other things: (i) marketing and promotion of the product in mainland China; (ii) conduct professional medical education activities for the product in mainland China. Turing will be responsible for warehousing, logistics, warranty, training and other support and after-sales services.
Under the terms of the distribution agreement, Shanghai Medtronic has the right to extend the term of the distribution agreement for three years if it reaches the cumulative three-year minimum purchase target, subject to the agreement of a new minimum purchase target. The Distributor Agreement may be terminated under certain circumstances, including in the event of a default, material default or insolvency.
In addition, subject to the terms of the Distributor Agreement, IceCure Shanghai will be responsible for obtaining and maintaining any and all regulatory approvals (“Regulatory Approvals”) required to market, promote, distribute, sell and use the Products in mainland China. NMPA, its local branch, or any other government agency (the “Regulatory Authority”). IceCure Shanghai has received regulatory approval for the IceSense3 System Console and requires regulatory approval for the IceSense3 disposable cryoprobe for commercial procedures within nine months from the effective date of the distribution agreement. Shanghai Medtronic has the right to terminate the distribution agreement if IceCure Shanghai does not receive regulatory approval for cryoprobes by then.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid nitrogen cryoablative therapy for the treatment of tumors (benign and cancerous) with cryotherapy, primarily targeting breast, kidney, bone and lung cancers. crayfish. Its minimally invasive technology provides a safe and effective alternative to inpatient tumor removal surgery, with a relatively short operation time and an easy-to-perform surgical procedure. To date, the system is marketed and marketed worldwide for FDA approved indications and is CE Mark approved in Europe.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “anticipate”, “anticipate”, “intend”, “plan”, “believe”, “intend”, “estimate” and similar expressions or variations of such words are intended to refer to forward-looking statements. For example, IceCure uses the forward-looking statements in this press release when discussing distribution agreements with Shanghai Medtronic and Turing, the company’s regulatory strategy, commercialization activities, and market opportunities for the company’s cryoablation systems in mainland China. Because such statements relate to future events and are based on IceCure’s current expectations, they are subject to various risks and uncertainties, and IceCure’s actual results, performance or achievements may differ from those described or implied by the statements in this press release. There are significant differences. . Forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the Company’s control, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F filed in SEC as of April 1, 2022 for the year ended December 31, 2021, available on the SEC website at www.sec.gov. The Company does not undertake any obligation to update these statements for revision or changes after the date of this press release, unless required to do so by law.