Treatment of Urinary Hesitancy

Photos by courtesy of ProArc Medical
Photos by courtesy of ProArc Medical

The tiny implant that allows the relief of symptoms resulting from benign prostatic hyperplasia

מרץ 2021

Male anatomy produces a stressful problem for men aged 50 and over, with partial to complete blockage of the urinary passage. The Israeli startup ProArc Medical presents an innovative mechanical approach to solving the problem, in a short and effective procedure, without compromising sexual function.

A trend that is expanding at an accelerated pace can be seen in the world of medicine in recent decades - the use of mechanical accessories to solve medical problems and alleviate medical conditions that impact on quality of life. Thus, if in the past doctors had two main therapeutic approaches available to them - use of medication or surgery - nowadays, it is possible to choose another path as well, based on a combination of engineering knowledge and medical need.

These accessories include a relatively new product - The Clear Ring, developed by the Israeli company ProArc Medical. The purpose of the product is to offer relief to men suffering from an enlarged prostate gland, whose number increases with age. In Israel alone, about a quarter of a million men suffer from the problem, and worldwide, it is tens of millions of men, if not more. The problem usually arises around the age of 50 and becomes more common as you get older. The commercial potential of ProArc's solution has also led it to succeed in crowdfunding, with Exit-Valley (see QR code), which is set to end during the coming weeks.

Since urine passes through the prostate, enlargement of the prostate impairs urine passage and creates a blockage, sometimes partial and sometimes even full, thus causing many problems related to urination, and to sexual function. Despite the commonness and severity of the problem, until recently there were only two main treatment types, which are far from providing a complete solution.

"The first option chosen most frequently is medication, which aims to slightly loosen the muscles in the area and produce a certain opening of the blockage," explains David Nitsan, CEO of ProArc Medical. "However, the medication is only effective for a limited time. Over the years, the patient develops resistance to the medication, its effectiveness decreases, and then usually doctors change the patient’s type of medication - and so on. This is a solution that is ineffective over time, expensive, and entails daily dependence.

"Next, when the medication option has been exhausted, the treatment offered to patients is non-reversible surgery. TURP surgery is considered the therapeutic standard (GOLD STANDARD). During this surgery, the prostate is accessed, and with an electric electrode, parts of it are cut away and removed through the urethra, thus solving the problem of urinary obstruction (the procedure is known as Transurethral resection of the prostate - TURP).

"In surgery there are two problems - first, it creates many short-term side effects, suc has pain, bleeding and loss of working days; whereas in the long run, we may observe lobe damage and retrograde ejaculation - a phenomenon that is very bothersome to men. For these reasons, many patients avoid surgery for years, but continue to suffer from the phenomenon, while there is no treatment that can alleviate their distress."

David Nitsan, ProArc Medical CEO

Allow the Flow of Urine without Interruption

ProArc's solution to the problem is a mechanical means - the Clear Ring implant is made of nitinol metal, which has properties highly compatible to the human body and in addition, has shape memory that enables us, as engineers, to adjust the implant shape to the anatomical organ in which we wish to place the implant. "In a procedure that takes place under partial anesthesia, the prostate area is accessed, the area is expanded using a balloon and a circumferential incision is created, where the implant will be inserted. The implant moves the prostate lobes apart, thus providing the urine with extra space, in which to flow uninterrupted. "The implant is protected from the urine fluid, and it is guaranteed the implant will remain in place over the years. Since it is not a surgery or a medication, the side effects after the process are very few, if any," says Nitsan.

The company has already conducted clinical feasibility tests at a number of medical centers in Israel and abroad. "We have seen that the product is effective and safe, and as mentioned, it has no negative effect on sexual function, and may even have a positive effect in the future. In addition, it is a completely reversible procedure, and the implant can be removed at any stage”, says Nitsan.

ProArc Medical has received recognition and grants from government bodies, including the Israel Innovation Authority, as well as from the EU's Horizon 2020 program. "We were also pleased to see a group of urologists from Florida, United States, investing their private time and money in the company. These days, we are preparing for the start of a multi - central clinical trial at three hospitals in Israel (Soroka, Rambam and Carmel), as well as at a medical center in New Zealand, with an opinion leader doctor, experienced in this field".

Huge Commercial Potential

The company's product, which is patent-protected, has a huge commercial potential - given the high proportion of men around the world suffering from an enlarged prostate. "Our goal is to provide them with immediate and long-term relief, without dependence on medication and without the side effects involved. Today, men aged 50 and over continue to be active, both sexually and in all other aspects, and we strive to enable them to enjoy a high quality of life, through an easy and simple procedure", concludes Nitsan. Behind ProArc Medical is serial entrepreneur Dr. Yair Feld an in terentional cardiologist from Rambam Hospital having a number of initiatives in the field of cardiology and urology. Nitsan himself is a biomedical engineer, who previously served as CEO of JetPrep Medical startup, which developed a product that improved the detection rate of cancerous lesions on colonoscopy examination, which was acquired to an American company.

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