Regrowth's Interview with Osmotics CEO Steven Porter

Osmotics CEO Steven PorterWe are aware that many of you have had many questions about FNS, so here are some of the highlights from the interview with Steven Porter, CEO of Osmotics.

Regarding Piliel’s previous trials and Life Medical Science: According to Osmotics, when the previous trials for Piliel were done, they did not use the original formula created by Dr. Ellenbaum. They modified it to try to preserve the live cultures used in the formula. Their alterations are what caused the product to not work as well as the original studies using the original formula. Osmotic’s version uses some new technologies which were not available at the time of the original Piliel trials to preserve the live cultures without using chemical preservatives.

The cost of the formula has not yet been set in stone yet, but will be around $60 for a 4 oz. bottle. A 4 oz. bottle is expected to last about 2 months, so the treatment will be around $30 per month in cost.

According to Dr. Ellenbaum, you will get most of the results you are going to see by the end of a year and after the first year you can use a maintenance approach of only applying the treatment 2-3 times per week, which will bring the cost down further.

The treatment appears to work just as well in the front of the scalp as in the back.

The treatment appears to help in almost all forms of hair loss whether it be genetic or due to other factors. Studies currently being done or planned hope to show that it will help prevent chemotherapy induced hair loss as well as prevent graft loss and telogen effluvium (shedding) in hair transplants.

The treatment works for women as well as men. Several of the original Piliel small scale trial participants who had good results were women.

FNS may help restore hair color and characteristics such as waviness that have gone away with age.

They are marketing FNS as a cosmetic and not seeking FDA approval due to the expense, so they are limited on the claims they can make. They are going to be doing some studies to help show effectiveness but plan to demonstrate effectiveness primarily through results of the product and marketing the product to dermatologists.

The treatment is best applied after showering so that there is no sebum on the scalp. They recommend application at night so that it can be on the scalp throughout the night. Use with other alcohol based topicals is not recommended, although oral medications such as Propecia are ok.

Osmotics is posting a news piece shown previously on the BBC regarding Piliel and showing results of some of its users.

Shipping through the US postal service will not affect the product as it contains enriched cell cultures but not live cell cultures.

 

Full Interview:

 

Regrowth: How close is your FNS product to the original Piliel formulation?

Osmotics: FNS is based on the original Piliel formulation. The only differences are that: (1) the product has been formulated to optimize delivery to the hair follicle and (2) the product has been formulated to be user friendly.

Regrowth: Since the postal service is attempting to sterilize all packages due to the recent biological terror attacks, is there any concern that that may cause a problem with the cellular cultures in your product, or will you be shipping through a freight service? Or is that a concern at all?

Osmotics: It’s actually not a concern because irradiation only concerns living cells – F N S is an enriched cell culture, not live.

Regrowth: The original formula contained a “…mixture of non-steroidal anabolic hormones including insulin at a wound healing effective concentration within the range of about 500 ng/ml to about 100 ug/ml, growth hormone at a concentration of about 0.5 ng/ml to about 20 ng/ml and triiodothyronine or thyroxine…”. Does the current formula contain these same hormones and if so how are you able to market the product over the counter without regulatory approval? If this is incorrect, what anabolic non-steroidal hormones does the formula contain?

Osmotics: Subsequent to the original research, Dr. Lindenbaum determined which of the active ingredients were the most effective and then simplified the formula. The exact components of the formula are proprietary and there is no regulatory problem in including any of the actives in this formulation.

Regrowth: How many people were involved in the studies that have been conducted to date that are mentioned on your site?

Osmotics: Fifty.

Regrowth: How did you end up being the company licensed to manufacture this product?

Osmotics: Osmotics contacted the Technion Institute and the Technion put us in touch with Professor Lindenbaum.

Regrowth: Does your company have any connection with Life Medical Science?

Osmotics: No.

Regrowth: What was the response rate as far as hair growth for the studies mentioned on your site?

Osmotics: The response rate was excellent. Professor Lindenbaum has submitted her data to the Journal of Online Dermatology. We hope that publication of the data will occur within the next few months.

Regrowth: Chief Executive Officer of Life Medical Sciences Robert P. Hickey said: “We felt we had sufficient information to conclude that PILIEL would not yield the desired benefit to the intended male users” when talking about their reasons for cancelling the Piliel trials. Do you know what his reasons were for this and why do you believe that you have overcome whatever obstacles there may have been at that time?

Osmotics: According to Professor Lindenbaum, Life Medical Sciences sponsored a small study in Europe. Unfortunately, the Company significantly altered the original formulation by adding large quantities of a bulking agent that interfered with the delivery of the formula to the hair follicles. Osmotics is working very closely with Professor Lindenbaum on the current formulation and we believe that consumers will be very pleased with the results.

Regrowth: Your site lists 4 oz of the product selling for $60. How long will 4 oz of product last?

Osmotics: Two months.

Regrowth: Do you have a more specific release date for the product? Will it be available in retail stores?

Osmotics: We anticipate availability someone in March. It will be available through our internet site (www.osmotics.com) and our retail partners.

Regrowth: Some people seem to experience a temporary telogen effluvium after starting Propecia and Rogaine prior to regrowth. Does your product cause any hair shedding?

Osmotics: No. In fact, we plan to evaluate the product for use in hair transplantation procedures to help reduce the shedding that commonly occurs following surgery.

Regrowth: How long after beginning use should you see a response?

Osmotics: Four to six weeks.

Regrowth: What testing have you done to insure that the product is safe for long term use?

Osmotics: Piliel was the subject of extensive toxicology studies which showed its safety.

Regrowth: Does the product have to be applied indefinitely to keep seeing the benefits?

Osmotics: No.

Regrowth: Have there been any studies showing how FNS affects DHT levels in scalp skin and in the follicle?

Osmotics: No. Professor Lindenbaum believes that the FNS mechanism is independent of DHT levels.

Regrowth: Have they examined its effectiveness at the front of the scalp in the hairline as compared to the vertex?

Osmotics: Yes. The FNS supplies nutrients to the hair follicles regardless of their location. The effectiveness is not limited by location.

Regrowth: Do you know if any of the study participants who grew hair had previously tried other medicinal treatments such as Rogaine and/or Propecia and did not respond to them but responded to FNS?

Osmotics: That’s an interesting question. I’ll pass it on to Professor Lindenbaum and see i the data from the study examined that relationship.

Regrowth: Have you done any testing on how the product will work for women with hair loss?

Osmotics: Yes. The product works for both men and women.

Regrowth: Your site mentioned FNS can affect the pigmentation of the hair. Will FNS help with gray hair?

Osmotics: Some study participants regained their original hair color. It may help is some cases.

Regrowth: Do you believe your product can help someone who is already bald and may have lost his hair several years ago?

Osmotics: If the hair follicle is dead, FNS will not bring it back to life. If it is dying, FNS may help to rescue it.

Regrowth: Do you believe your product would help grow hair in other places where it was lost, such as the eyebrows?

Osmotics: If the hair follicle is still alive,FNS will help the follicle regain its vitality.

Regrowth: Will FNS help regrow hair on the scalp that his been damaged through medicinally caused hair loss or hair loss caused by a non-genetic cause of hair loss?

Osmotics: Professor Lindenbaum has conducted studies with children who lost hair due to chemotherapy and radiation therapy treatments and the results were quite satisfactory.

Regrowth: Do you recommend FNS for use with children who have hair loss problems?

Osmotics: We recommend that all persons who are experiencing thinning hair or who use to revitalize their existing hair use FNS.

Regrowth: Can FNS be used at the same time as other topical treatments such as Rogaine are in use?

Osmotics: Yes.