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Men at Work

The History of the Breast Reconstruction Application

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Written by Fas Kuiters

At the closing of the Olympus hardware deal in November 2005, "super-charged" soft tissue transfer wasnt really in the picture of shareholders at all. During the CC of this event the first mention thereof was made as well as the potential of the fistula after Crohn´s and PVD (Peripheral Vascular Disease) applications.

Marc Hedrick mentioned in this conference call- "in addition, plastic and reconstructive surgery and prevascular surgery also represent important digital clinical opportunities that are still in the pre-clinical stage"

Yes-sometime in 2005 (at the time that Olympus was doing its due-diligence) somebody must have gotten the idea, that this type of low hanging fruit was an important part of the technology use and started investigations on graft retention for breast reconstruction after lumpectomy or partial mastectomy. Cytori soon started pre-clinical work on that and in April 2006 Cytori scientist Dr. Min Zhu presented the results of fatgraft retention in rodents at a plastic surgery conference in Miami. The announcement thereof you can read here. LINK HERE

 

Fortunately already before this announcement, there were Japanese medical people like Kaoru Kitamura (picture below) and Keizo Sugimachi from Kyushu Central Hospital, picking up the baton very very fast (March 2006) using Celution in a "private investigator sponsored trial" (if you believe it) for breast reconstruction after lumpectomy, that clinic, we now all refer to as RESTORE I.

kitamura-kaoruI still wonder who got matters rolling there-Olympus? Cytori? or was it pure luck? Dont think there is luck in this business though, especially in view of average timelines required for getting IRB approvals, trial design and the whole lot. Somebody with the appropriate influence in the land of the rising sun must have accellerated the process of getting the clinic moving nicely.

Anyway- already in late 2007- accompanied by another pre-clinical rodent paper from Cytori pdfposter4072.pdf91.18 KB02/07/2012, 15:24- the results of RESTORE I were already presented at the San Antonio Symposium on Breast Cancer by Kitamura and Sugimachi- pdfposter4071.pdf263.2 KB02/07/2012, 15:25 . Very fast indeed.

Cytori´s clinic RESTORE II on breast reconstruction in Europe

Early 2008, at about the same time that Sugimachi had presented his 12 months results on RESTORE I, which showed that after this time frame, no significant tissue loss was noted at his 21 angelabrooks-restoreiipatients treated, Cytori announced the start "to come" of RESTORE II a 70 patients trial to be led by Emmanuel Delay in Lyon. France introduced a moratorium on soft tissue transfer, so no IRB approval was received and Eva Weiler-Mithoff in Glasgow picked up the baton and moved the trial forward in the UK.

Most cosmetic surgeons will tell you, that retention of volume is virtually assured after 3-4 months, since in that timeframe the cells complete their work and provide the angiogenesis impact of assuring blood supply to the new tissue to prevent necrosis thereof. Nonetheless the 12- and in particular the 24 months follow-ups are very important for the KOL´s (Key Opinion Leaders) and insurance carriers to finally adopt the technology. Both RESTORE I (Sugimachi) and RESTORE II are beyond their 24 months points and results are excellent

Several articles appeared in the press on RESTORE II- of which the one with Irene McKenzie (picture) - as first patient- surely was the best link here

From 2009 dates a video produced by San Francisco´s NBC Channel 11, which also features Irene and other patients, together with an explanation of the technology. This one is pretty good. See below 

 

For any further information I highly recommend to visit Cytori´s website- Cellreconstruct.eu, which features all relevant information on the application, Update_ unfortunately website has been taken off the web.

The work of Pud Bhaskar at Hartlepool Hospital UK

Almost parallel to RESTORE II some NHS hospitals carried out their own investigation on the procedure. 23 women were treated and reported upon by PI Pud Bhaskar on May 16th 2011 in Manchester- This presentation highlighted results from an independent, prospective study of 23 patients who received ADRC-enhanced fat grafting for the correction of breast contour defects following cancer treatment or benign conditions including implant complications, using the Celution® System. Patients were treated between September 2008 and November 2010 and followed up between 3 months and 2 years. Follow-up survey data was obtained to assess patient and investigator satisfaction with symmetry between the breast, size and shape of the breast, breast softness, and appearance of the scar at the donor and treated site.

The results showed 82% (19) of patients reported good to excellent results with a mean satisfaction score of 5.1. Satisfaction scores ranged from 1 (worst) to 6 (best).The results further showed a high level of investigator satisfaction with a mean satisfaction score of 4.3. Study findings demonstrated a low complication rate. Overall, the study results suggest the RESTORE procedure is a viable option for breast reconstruction with no safety concerns."The practical applications for the use of ADRC-enhanced fat grafting are expanding from simple volume replacements to use as an adjunct or alternative to traditional methods of breast reconstruction," commented specialist surgeon Mr. Pud Bhaskar, lead investigator. "The procedure has low rates of fat resorption, is simple and safe to perform. We, and more importantly our patients, are highly satisfied with the operative outcome
A few months later BBC North broadcasted a news video, which you can only find here on this page. See above.

Further steps required for commercialization.

Meanwhile the UK agency reviewing new innovative procedures- NICE- has evaluated the Cytori breast reconstruction procedures and reported it to have great benefits to patients and being cost effective i.e. saves a lot of money for the UK healthcare system compared to alternative treatments. This recommendation is the first step for the procedure to be included in the UK DRG system (Diagnosis Related Groups) which determines reimbursement of procedures on patients by the NHS. The coding for the DRG is key for the success of the application revenue-wise.

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