Medtronic Partner IceCure Medical Faces Potential Delisting Amid Nasdaq Compliance Notice

Nov 05, 2023 18:49 CST Updated 18:49

IceCure Medical

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Recently, IceCure Medical, the global leader in minimally invasive cryoablation technology, announced that it has received a written notice ("Notice") from The NASDAQ Stock Market ("NASDAQ").Indicating that the company does not comply with the minimum share price requirement for continued listing stipulated in Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum share price of $1.00 per share.

It is reported that IceCure Medical, founded in 2006, began trading on the Nasdaq on August 26, 2021, under the ticker symbol "ICCM." The company develops and markets an advanced liquid nitrogen cryoablation therapy for treating tumors (both benign and cancerous) through freezing. Its primary focus areas are breast cancer, kidney cancer, bone cancer, and lung cancer. The products have received CE, FDA, and NMPA approvals.It is still a partner of Medtronic. According to Nasdaq Listing Rule 5810(c)(3)(A), it has a compliance period of 180 calendar days to regain compliance with Nasdaq's minimum bid price requirement.

Medtronic Partner May Withdraw from the Market

IceCure Medical, founded in 2006 and headquartered in Caesarea, northern Israel, is a leading medical device company in the field of cryoablation.Committed to achieving optimal minimally invasive treatment options through cryoablation and introducing advanced minimally invasive cryoablation therapies into women's health and interventional oncology to transform treatment methods, playing an active role in patients' cancer treatment.

On August 26, 2021, IceCure Medical officially began trading on the NASDAQ under the ticker symbol "ICCM" while maintaining the listing of its ordinary shares on the Tel Aviv Stock Exchange. Prior to the NASDAQ listing, the company completed a $15 million private placement in January 2021.

Medtronic's Partner

Notably, it is also a partner of Medtronic. On June 12, 2022, IceCure Medical signed an exclusive three-year distribution agreement with Medtronic Shanghai and Turing Minimally Invasive.According to the agreement, Medtronic Shanghai will become the exclusive distributor in mainland China for IceCure Medical's minimally invasive cryoablation tumor treatment system, IceSense3, including its devices and consumable probes. Turing Minimally Invasive will be responsible for importation, installation, and service. The minimum purchase amount within three years is $3.5 million. Additionally, Medtronic Shanghai will not collaborate with any competitors of IceCure during the agreement period and for six months thereafter.

May Be Delisted

However, IceCure Medical's performance in the secondary market has been lackluster. On November 3, 2023, the company disclosed that it had received a written notice ("Notice") from The NASDAQ Stock Market ("NASDAQ"),Stating that it does not meet the minimum share price requirement for continued listing stipulated in Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum share price of $1.00 per share.

According to the notice,The company must regain compliance with the minimum bid price requirement by April 29, 2024. If at any time during this 180-day period, the closing price of the company's common stock is at least $1.00 for a minimum of ten consecutive trading days,The company can regain compliance, in which case the company will receive written confirmation of compliance and the matter will be closed.

If the company does not regain compliance after the initial 180-day period, it may be eligible for an additional 180-day compliance period if it meets the continued listing requirement for public float market value and all other initial listing standards of the Nasdaq Capital Market (excluding the minimum bid price requirement). In this case, the company needs to provide written notice stating its intention to remedy the deficiency during the second compliance period. If the company is unable to demonstrate compliance within the prescribed compliance period, Nasdaq will notify the company that its common stock will be delisted.

In response, IceCure Medical stated that it will monitor the closing price of its common stock, and continued listing on Nasdaq remains a top priority for the company. If the situation does not resolve itself within the aforementioned timeframe, the company intends to consider available options to address the deficiency and regain compliance with the minimum bid price requirement within the compliance period.

Recurrence-free rate as high as 96.91%

It is reported that IceCure Medical has primarily developed the ProSense cryoablation system, which uniquely utilizes liquid nitrogen cryoablation to treat tumors, maximizing the destruction of benign and cancerous lesions (including those in the breast, kidney, lung, and liver).With its simple, transportable design and use of liquid nitrogen, the ProSense system enables reliable cryoablation in office or radiology settings.

During the procedure, under the guidance of CT or ultrasound, the ProSense system's cryoprobes are inserted into the tumor, and liquid nitrogen generates extremely low temperatures, turning the tumor into an ice ball.The freeze-thaw-freeze cycle immediately destroys the target tissue, while the adjacent healthy tissue remains undamaged, and the necrotic fragments are eventually absorbed by the body.

Since the ProSense system uniquely uses small, low-pressure liquid nitrogen dewars, it is different from argon-based cryoablation devices.No need for gas pipelines, on-site technicians, or specific safety rooms to store large and hazardous high-pressure gas cylinders.。

At the same time, the ProSense system is easy to install, with the shortest program setup time. The touch-screen system provides an intuitive user interface, step-by-step instructions, and preset freeze-thaw-refreeze programs, supporting multiple languages. The system comes in two configurations—90° and straight handle—suitable for various types of cryoprobes, allowing optimal adjustment of the size and location of the lesion.

In addition, the ProSense system has a unique cryoprobe system, allowing doctors to save time and provide an efficient procedure with reliable results. Compared with other systems, doctors can effectively treat the same tumor using only one cryoprobe instead of multiple cryoprobes.

The ProSense Single-Low-Temperature Probe System also simplifies setup time, requiring only one functional test, reducing navigation time, and helping doctors minimize potential complications. In a single procedure for treating larger tumors or multiple lesions, a single cryoprobe can be repositioned up to three times for each patient.

The non-recurrence rate is 96.91%.

IceCure Medical conducted a trial named "ICE3 Study" on the ProSense system, which is the largest multi-center clinical trial ever performed in the U.S. for cryoablation with liquid nitrogen in early-stage breast cancer. Mid-study results showed a recurrence-free rate of 96.91%, 100% safety, and 100% satisfaction among both physicians and patients regarding cosmetic outcomes.Recent independent research has shown similar results in Europe. The ICE3 trial is expected to be completed in the first quarter of 2024.

Dr. Tomkovich, a diagnostic and interventional radiologist at Princeton Radiology, Central State Medical Center, and Princeton Medical Center of the University of Pennsylvania, stated: "The interim results of ICE3 show that patients with early-stage breast cancer are achieving recurrence-free outcomes comparable to the current gold standard of surgical tumor excision. Given the additional advantages of image-guided cryoablation using ProSense, including the ability to be performed in an outpatient setting, requiring only local anesthesia, minimal recovery time, and excellent cosmetic outcomes, cryoablation has proven to be an excellent choice for suitable patients."

Disposable Cryoprobe Approved by NMPA

On March 28, 2023, IceCure Medical's disposable cryoprobe was approved by the NMPA for marketing and sales in China.When used in conjunction with the company's IceSense3 console, which was previously approved by the NMPA, it will continue to be distributed by Medtronic Shanghai.

With this latest approval, the company and its partner in China can leverage their novel and established technologies to treat malignant and benign tissues of the breast, lung, bone, liver, and kidney, as well as for palliative interventions, addressing a significant market demand.

Currently, the ProSense system has received CE, FDA, and NMPA approval and is commercially available worldwide, including in the United States, Europe, and China, with a primary focus on breast cancer, kidney cancer, bone cancer, and lung cancer.

The market potential is significant.But there are fewer approved products.

Cryoablation is a method that uses low-temperature technology to freeze diseased tissue, thereby achieving in-situ inactivation of solid tissue. The principle involves using low temperatures to rapidly cool the diseased tissue to destroy cells, causing cell necrosis or apoptosis, and thus achieving the therapeutic purpose.

Since cryoablation adopts the physical method of energy exchange to achieve therapeutic purposes, its trauma and side effects on the human body are much lower than conventional radiotherapy and chemotherapy, thus being praised as a "green therapy."Percutaneous cryoablation technology for tumors, with a series of advantages such as large ablation range, painlessness, no need for general anesthesia, clear treatment boundaries, and real-time imaging monitoring, is considered a highly promising local ablation technology and has been rapidly promoted in clinical practice in recent years.

In the cardiovascular field, compared with traditional radiofrequency ablation,Cryoablation technology has many advantages, such as safer surgery, good patient tolerance, wide range of indications, fewer complications, and less likelihood of thrombosis.`, and the operation time is significantly shortened, with a short learning curve.`

The market concentration of cryoablation devices is relatively high, which is mainly caused by the production scale of upstream raw materials and related production technologies for cryoablation devices.Overall, the total sales volume of the global cryoablation equipment industry in 2021 was around 280 units, with an annual sales revenue of 131.81 million US dollars.

In terms of revenue,The global cryoablation devices market was valued at USD 131.81 million in 2021 and is expected to reach USD 662.38 million by 2028, with an average annual growth rate of 25.38% from 2022 to 2028.In terms of consumption, the global number of cryoablation devices reached approximately 280 units in 2021 and is expected to reach about 1,720 units by 2028, with a CAGR of 28.84%.

According to data from Frost & Sullivan,The market size of interventional cryotherapy devices in China increased from RMB 98 million in 2016 to RMB 391 million in 2020, with a compound annual growth rate (CAGR) of 41.3%.It is expected that by 2030, the market size will reach 11.234 billion yuan, with a compound annual growth rate of 40%.

In terms of the layout of enterprises, the current leading suppliers in the industry include Boston Scientific, Siemens, HaiJieYa, IceCure Medical, etc.

As the leading medical device company in the field of cryoablation,Icecure MedicalBy virtue ofProSense System Continues to Expand in the Global Market, but the Limitation of a Single Product is Also a Significant Issue. This Time, After Receiving the Delisting Notice from Nasdaq, the Company Responded that It Will Focus on Its Stock Price and Strive to Meet the Listing Requirements Again. Thus, Within 180 DaysIcecure MediCan cal boost its stock price? In this regard, Instrument Family will continue to follow up.

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