Notes of $BTX Renevia Pivotal Data Conference Call 14.6.2017
Patient’s own fat cells transplanted with Renevia.
26 – 21 control group.
5CC in each side. 5.1 CC after 6 months found. Very High statistical proof of efficacy. 6m- 95%, 12m 93% volume retention. May be better in Non HIV patients.
Well position to compete in facial aesthetics (fat transfer lasts 6 – 12 months then need again).
File CE up to end of year, then available commercially in Europe in 2018.
1Million HIV in Europe, ~ 300 with facial atrophy.
Dr. Ramon – the treating doctor practice in Palma de Mallorca – Stem Europe Center.
Excited about the results. High volume retention rate is compelling. Also safe and well tolerated in sick patients.
Unmet clinical need. Effective transfer of adult fat stem cells. Combined with Renevia, enabled effective delivery.
Positive finding that we may be adding new cells !
Applicable to other practices (breast reconstruction, for eg).
Plastic surgeons might be able to use this.
Implants loaded with cells is very large use probability.
Plan to develop Renevia.
Working on Flexible Platform to allow surgeons to use it in many ways.
PT additional trial: Larger volume of Revenia.
Expects Revenue in 2018 with long runway of growth, additional uses, TAM multi Billion $ market.
Q&A:
1. Patients: First time and recurrent (fillers) and dissatisfied from it. Very homogenous sample of patients.
2. Bar for EU approval what is required & how long?
a. Data today is all needed to file and sufficient for approval (no need for more data), just wait for full data (this is top line results). Couple of months. Efficacy and safety is done.
b. Timeline: CE Mark process (3-6M), depends on agency overload. 1H2018 is a not unreasonable expectation to get CE approval.
3. Potential partnering: Several ways to commercialize. Discussions progressing. Remain open for everything. For EU (Non US) Commercializing via partner seems like the best way. Partner with capabilities in plastic surgery arena minimizing investment in global infrastructure at this point, keeps us heavily involved in development and evolution of this product. Renevia might be able to do lots of things and shortly more data will be added supporting “so many other possible uses of Renevia”. Several conversation with partners (Asia, Europe). Hope to move this along faster. More in the coming months.
4. What more clinical trials are needed:
a. We have a US clinical trial in Non HIV Renivia with fat cells (Patients will get whatever size / shape transplant/implant they what to satisfy aesthetic needs) . Starts this month – data soon.
b. This Data is good not only for EU but with the Non HIV patients results and with some more data from Dr Ramon additional studies soon to generate data: That will be supportive of (1) planned conversation with FDA about A General Facial Fat Loss Indication trial, (2) Additional indications we want (informed by real life use of the product in the market – the Drs will provide knowledge and feedback to expand label as well as possible uses identified by the company).
c. Partnering Opps. Asia: Will you need more clinical trials there?
i. This data is sufficient for Serious Partnership conversation worldwide. Substantial Trial.
ii. (didn’t want to answer about more trial elsewhere at this time).
d. 3D scanner – how accurate to assess the volume gain?
i. There was published study about it. It demonstrated statistical significance between CT scans, MRI and 3D scanners. It is a standard accepted to prove change in volume (FDA).
ii. Further validated it with additional studies until confidant of the appropriateness of this technology. 0.2CC accuracy.
e. How to assess new tissue growth?
i. In vitro conditions we saw the cells were very happy: three dimensional existence of cells.
ii. The cells are not disappearing, but volume is retained – although the scaffold is disappearing!
iii. Homogeneous, well vascularized tissue exists.
iv. One biopsy supported the assumption that this is a new live, tissue.
v. Implantation site hardens then softens, and it feels there is real tissue there. Ultrasound should there is no foreign body there but natural tissue vascularized – very probable.
f. End of Q3 data?
i. Full report, Secondary endpoint (Aesthetics Score – anecdotal not significance), 12 months follow up, correlation to BMI.
g. Reconstructive procedures for Renevia:
i. It’s a significant platform – plastic, breast, body contouring, facial, orthopedic surgeries are candidates.
ii. Trauma uses (Orthopedic), muscle, tendon, joint disease are candidates.
iii. In next studies – will pursue these thing: Step 1: Non HIV patients (validates that Renevia works better in healthy patient), Step 2: long list of possible uses – Seems like the medical doctors have more Ideas than the company – great sign.
h. EU Partnership: candidates? Initiated discussion.
i. Completed conversations, advanced conversations – guidance pretty soon.
Possessing an approved, validated therapeutics that does much better than current standard of care, with a Massive TAM is a huge deal. BTX is significantly de-risked today. Not long to wait for the Therapeutic to start generating cash flows. Good Day.
