FDA Nod for Paxman’s Scalp Cooler April 19, 2017

Paxman-Scalp-Cooler

The U.S. FDA has cleared the company to market the Paxman Scalp Cooling System, meaning that US breast cancer patients undergoing chemotherapy will now have access to this potentially hair-loss reducing system.

Background

Covered before on our pages, the Paxman Scalp Cooling System owes its origins to mother of four, Sue Paxman, who experienced first-hand the trauma of chemotherapy-induced hair loss. Sue’s legacy lives on, the company now helping women around the globe minimize chemotherapy-induced hair loss and contribute to their quality of life.

Scalp cooling works by reducing the temperature of the scalp by a few degrees immediately before, during and after the administration of chemotherapy. Vasoconstriction reduces the amount of chemotherapy that reaches the hair follicles, reduced drug diffusion through the cell membrane, decreased cell division, reduced active transport mechanisms, and a general reduction in metabolic activity.

With over 2500 systems in hospitals, clinics, and treatment centers around the world, Paxman plans to start its U.S. venture by installing 250 systems across the country, and will be working with a large number of cancer centers and large community oncology groups.

The company’s stated aim is to revolutionize the scalp cooling landscape by ensuring that affordability is at the center of the treatment giving more patient choice. This involves launching a single patient use personal cap model, which will be loaded with scalp cooling “credits,” depending on the number of chemotherapy infusions to be administered. Patients will only pay for their own cap and the treatment they use.

As part of the FDA clearance process, the Paxman scalp cooler was used in the first-ever randomized clinical trial to evaluate modern scalp cooling, which took place at a number of sites including Baylor College of Medicine, Memorial Sloane Kettering, the U.S. Oncology Network, Cleveland Clinic & Summit Medical Group – MD Anderson Cancer Center.[1]

The multi-center prospective study, which involved 186 women across New Jersey, New York, Texas, and Ohio, revealed that the cold cap preserved hair in more than 50% of the women who used it.

Investigator comments

Speaking about results lead researcher Dr. Julie Nangia, MD, Assistant Professor of Medicine at Baylor College of Medicine, Houston, Texas, USA added: “The Paxman Hair Loss Prevention System is a safe and effective method for reducing hair loss in women being treated with chemotherapy for breast cancer, especially for those on taxane-based regimens.”

“Hopefully in five years from now, we will consider scalp cooling part of routine practice, the same way that we can see an IV-pump with an IV-pole as part of the regular equipment you would expect in an infusion suite. It’s important that people undergoing chemotherapy understand what scalp cooling is and that it is an option available to them if they want to prevent hair loss.”

Company comments

CEO Richard Paxman said: “The USA is the largest healthcare market in the world with over 1.6 million diagnoses of cancer each year. We have spent six years conducting a comprehensive multi-center randomized clinical trial to ensure our data is as robust as possible. This has been a significant investment for us, but we are incredibly excited to be able to offer scalp cooling to US patients giving them a choice to maintain some control during treatment as we see in the UK and other parts of the world.”

Ref: [1] Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK1, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939.

Source: Paxman Coolers Ltd.


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