FDA

IceCure’s ProSense Breast Cancer Treatment Receives Landmark FDA Approval

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Israel’s IceCure Medical, developer of a minimally invasive system that destroys cancerous tumors by freezing them with liquid nitrogen, announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for its ProSense cryoablation system to treat breast cancer. The indication covers women aged 70 and above diagnosed with early-stage, low-risk breast cancer. According to the company, approximately 36,000 women in the U.S. are diagnosed each year with this specific subtype of the disease.

The approval marks the most significant regulatory milestone in IceCure’s history and represents the first and only cryoablation-based treatment ever approved by the FDA for breast cancer. Following the announcement, the company’s shares surged more than 17% in after-hours trading on Nasdaq.

The FDA’s decision is based on results from IceCure’s ICE3 clinical trial, the largest study ever conducted to evaluate cryoablation for early-stage breast cancer. The five-year trial, held at 19 medical centers across the U.S., enrolled 206 women with low-risk tumors. The results showed a 96.3% rate of no local recurrence, no serious device-related adverse events, and high patient satisfaction, including excellent cosmetic outcomes. The findings were published in the Annals of Surgical Oncology and formed a key part of the FDA’s decision-making process.

A Five-Year Competitive Advantage

The approval followed a vote by a special FDA Advisory Panel convened specifically for this purpose. The panel determined that any competitor seeking to market a similar system will not be eligible for the FDA’s 510(k) clearance pathway, and will instead need to conduct its own clinical trial with supporting data. This effectively grants IceCure a competitive advantage of at least five years over potential rivals.

Following the approval, IceCure is establishing a U.S. sales team to support commercial rollout. As part of the FDA’s requirements, the company will conduct a Post-Market Study after product launch. IceCure considers this an advantage, as the study will be carried out in collaboration with leading medical institutions across the United States, accelerating adoption of the technology in clinical settings.

IceCure’s system already holds a CPT3 reimbursement code that provides initial insurance coverage for the procedure, a move expected to ease adoption among hospitals and physicians. The ProSense system is also CE-marked in Europe and approved by Israel’s Ministry of Health, but the company expects the FDA authorization to further drive adoption in existing markets and assist in securing regulatory approval in Japan, one of its key target markets.

In an interview with Techtime, IceCure CEO Eyal Shamir said:
“Our main focus in recent years has been breast cancer, as our system offers clear technological and economic advantages in this indication. This approval is a breakthrough not only for IceCure but for the entire field of breast cancer care. Now that we’ve achieved regulatory clearance, we are entering the execution phase and plan to accelerate commercialization in the U.S. Our treatment provides a non-surgical alternative for women over 70 diagnosed with early-stage breast cancer.”

Liquid Nitrogen Delivered Directly to the Tumor

Founded in 2006, IceCure developed a system based on cryoablation technology, which eradicates tumors through controlled freezing. The minimally invasive procedure involves inserting a thin, ultrasound-guided needle—protected by 11 patents—directly into the tumor. Once in position, liquid nitrogen is circulated through the tip, freezing and destroying the cancerous tissue while preserving the surrounding healthy tissue.

The procedure typically lasts 20 to 40 minutes, requires only local anesthesia, and does not need an operating room. Unlike competing cryoablation systems that rely on expensive noble gases such as argon or helium—with smaller freezing zones that require multiple probes—ProSense uses liquid nitrogen, allowing for a wider treatment area, fewer probes, and lower costs.

Cryoablation is particularly effective for early-stage tumors, making early diagnosis essential for treatment success. In recent years, IceCure has focused its business and clinical strategy on early-stage breast cancer, believing the company’s technology offers the strongest therapeutic and cosmetic advantages—achieving high recovery rates while eliminating the need for partial mastectomy and preserving the natural appearance of the breast.

“IceCure is about to achieve the ‘holy trinity” in medical device market” 

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IceCure Company, the developer of cryoablation-based cancer tumor destruction system, is preparing for the most significant phase of its technology commercialization. A month ago, the company had submitted regulatory filing (De Novo Classification Request) with the FDA for marketing authorization its ProSense system as an approved procedure for treating early stage breast cancer. For several years IceCure market its ProSense system in various markets and for different cancers such as liver, bone, and lungs cancer. nevertheless, receiving an FDA approval for the current submission will open the major market the company targets: breast cancer patients in the United States. 

The company estimates that about 40,000-60,000 annually diagnosed women across the USA  meet the indication’s criteria and will be able to undergo the treatment, following FDA approval. The innovative process is conducted by inserting thin needles into the tumor and  generating, using liquid nitrogen, a sub-zero temperatures ice sphere at the tip of the probe and obliterate the tumor by freezing. This method is tissue-harmless, thus there is no need for breast excision surgery, nor any other cosmetic damage is taking place. The minimally  invasive procedure is completed in less than 30 minutes and no full anesthesia is required.  

In the medical device market, an FDA authorization is indeed a mandatory precondition, however, such authorization is not a warranty for commercial success. As part of its preparation for the opening of the new market, few months ago IceCure brought to its ranks Mr. Gilad Glick, formerly CEO of Itamar Medical, as a strategic advisor to the Company. Glick will assist the company in establishing its marketing and sales infrastructure in the USA and in forming its go-to market strategy. 

The medical device companies’ trinity 

IceCure hope that Glick will be able to reproduce Itamar Medical’s business success during  his term as the CEO. Itamar Medical developed a wearable medical watch to aid in the diagnosis of respiratory  sleep disorders. The main advantage of the device is by being a non-invasive, user-friendly  instrument that provides the ability to diagnose sleep disorders in the patient’s house and  not spending the night in a sleep lab. Glick was CEO of Itamar Medical from 2013  through 2021 when Itamar Medical was acquired by ZOLL Medical Corporation for $538 million at the end of 2021. From $2.3 million revenue in Q1 2017, the company’s revenue increased to $12.6 million in Q2 2021. Glick is also well familiar with the American market,  which constituted 80%-90% of Itamar Medical’s revenues. Glick is marketing and sales oriented, and before joining Itamar Medical he held the position of VP Worldwide Sales and Marketing for Biosense Webster, a world Cardiology leader. 

In a conversation with Techtime, Glick explains: “Throughout my whole career I was engaging in commercializing medical technologies. For a medical equipment company, the holy trinity that makes it possible to generate value is quality clinical data, finding solution for a medical issue not yet resolved or without a proper alternative, and insurance indemnity. IceCure is approaching towards this value creation, and it is currently in the most  interesting phase in the life of a medical equipment company”.  

Recently, IceCure published the results of an extensive clinical experiments held in the USA. For 5 years, the research followed 196 patients that went through the new procedure. Thus far, only six patients (3%) experienced cancer recurrence. The results of this research formed the basis for the last FDA approval request, and it should be the basis for future indication expansion, in order to increase the future target patients. 

ProSense: Needles flow nitrogen into the tumor

Beyond the high recovery and the low recurrence rates, a major added value of the system, and a one that differentiate it is the fact that the procedure causes no damage to the tissues surrounding the tumor. The liquid nitrogen is flowed directly into the tumor through the  needles, without harming any tissue. Then, when the tumor is frozen, the remains are gradually draining through the lymph nodes. Usually, when a breast tumor is discovered, a partial breast excision surgery is required in order to prevent the tumor’s growth. 

“The surgery alternative, a breast excision, is highly invasive and fundamentally changes the  patient’s body. We offer a non-invasive alternative that does not change the shape of the  breast. This is a huge advantage in in the medical equipment world nowadays: offering a non invasive alternative for a traditional, invasive procedure. Also, some of the patients underwent the surgery need additional operation in the future, something that our treatment eliminates”. 

Until now, without the FDA approval, the most strategic market of the company’s operation  is the East-Asian market. The company had been granted regulatory approvals at several countries, including Japan. However, the revenues from this market stay modest in the past years. IceCure operates in this market through cooperation with Terumo, the giant Japanese medical equipment company, who serves as the exclusive distributor in Japan, Singapore, and Thailand. However, profit margins are lower in distribution model, and the marketing initiatives, as well as the communication with the local medical bodies, are in the hands of the distributor. 

Within the American market IceCure operates through subsidiary and is intended to mange the marketing and sales channels by itself. “Commercializing medical technology is a  coherent doctrine. It is a process to be prepared for. My role is to prepare the company, so  we will be ready to accelerate the commercialization in the minute we receive the FDA approval. We establish our sales force and the supporting infrastructure, the marketing strategy, and the messages. There are various fields we can approach, from Interventional  radiology, breast cancer surgeons and Interventional Oncologists – and we must suit the messages and the proper marketing channel for each of them”. 

Check-Cap initiated pivotal clinical trial in the U.S.

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The medical device start-up Check-Cap, which has developed an X-ray capsule which performs screening test to detect polyps in the colon, announced the initiation of U.S. pivotal trial. The trial was delayed for over a year due to the COVID-19 crisis. At the completeness of this trial and based on the result, the company will file a request to obtain FDA clearance for its innovative C-Scan® system, intended to be the first and only patient-friendly replacement for traditional Colonoscopy test.

The trial will be conducted at the Mayo Clinic Medical Center in Rochester Minnesota, as well as in other medical centers. Mayo Clinic is one of the most respected academic medical centers in the U.S. and around the world, and is in collaboration with Check-Cap for several years.

The trial will include approximately 1,000 subjects ages 50-75 and will be conducted at up to 15 clinical centers in the U.S. The trial is composed of two phases; the first phase will be served as additional calibration of C-Scan for the average risk U.S. population and will enroll up to 200 subjects. The second phase consists of a statistically powered, randomized study which will compare the performance of the system to traditional colonoscopy and will enroll approximately 800 subjects. Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic, will be the principal investigator of the study at this site. 

Check-Cap, located in Isfiya near Haifa, Israel, develops an ingestible capsule-based system for preparation-free colorectal cancer screening. The C-Scan utilizes ultra-low dose X-ray and an wireless communication sub-system. The capsule is used to create a 3D map of the inner lining of the colon, which allows physicians to look for polyps and other abnormalities. C-Scan is non-invasive and requires no preparation or sedation, allowing the patients to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.

“We are excited to announce the accomplishment of this important milestone in our path to demonstrate the potential of C-Scan to detect colorectal polyps before they may turn into cancer in the average-risk population,” said Alex Ovadia, chief executive officer of Check-Cap. “We are pleased to have engaged with expert gastroenterologists at Mayo Clinic and continue to advance the participation of additional experienced clinical trial centers in this study. We have established a supply and distribution infrastructure and process of the C-Scan and our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022.”

Mr. Ovadia continued, “Detecting precancerous polyps is needed to effectively prevent colorectal cancer. However, the acceptance of the colonoscopy procedure is low, in part due to the invasiveness of the procedure and bowel cleansing. We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting.”

The FDA approved Insightec system for the treatment of advanced Parkinson

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The U.S. Food and Drug Administration (FDA) has approved Insightec’s system for treating advanced Parkinson Disease (PD) patients suffering from rigidity, mobility and dyskinesia symptoms. This is a significant expansion of Insightec’s system clinical indication, which until now was approved for treating PD patients experiencing essential tremor. Last month Insightec signed a merger agreement with a SPAC in order to list on Nasdaq with a company valuation of $2 billion. The new clinical indication extends the potential market for the company’s system. Currently, one million patients in the United States are coping with PD.

The system developed by Insightec is a minimally invasive surgery (MIS) technique, used for treating symptoms such as essential tremor and benign tumors in the uterus using focused ultrasound waves. Within the new clinical indication, Insightec’s system may be used as an incisionless method of performing a process called Pallidotomy, which is used to ablate a brain area called globus pallidus. Until now, the only method of performing Pallidotomy was to place a tiny electrical electrode in the globus pallidus, which is then heated and destroy a small area of brain cells. Using Insightec’s device, this process could be performed incisionlessly, by externally focusing the ultrasound waves to the target area. In many cases, this process reduces the severity of the patient’s symptoms.

Founded in 1999, Insightec developed the Exablate platform which provides non-invasive treatments for a variety of oncology and gynecology indications. Exablate Neuro uses focused ultrasound waves to target and ablate tissue deep in the brain with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring.

In May 2017, Insightec received FDA Approval for Exablate Neuro fo the treatment of essential tremor. Following the approval Insightec has decided to initiate a pivotal study of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson’s disease patients who have not responded to medication.

Parkinson’s disease afflicts millions of people worldwide, including approximately one million in the United States alone with 60,000 additional diagnoses each year. Treatment with the Exablate Neuro is intended to improve motor function and reduce dyskinesia, one debilitating symptom that presents as uncontrolled, involuntary movement of the arms and/or legs.