News & Trends

A new patent pending mobile app from Nano 2.0 Business Press, LLC aims to allow dermatologists and plastic surgeons to meet growing patient demand for mobile applications. AppForMyPatients (appformypatients.com) is a software as a service (saas) platform.

“We are the only software that combines a free mobile app for patients along with cloud based software for the physician to provide skin care retailing functionality, connectivity and business intelligence to physicians” says founder Steven M. Hacker, MD. “Finally, physicians, like traditional retailers, can have access to patent pending software that creates dynamic retail pricing, and reveals anonymized competitors' pricing in different markets and specialties. Our software creates an instant app with numerous powerful functions that independently complements any website, patient portal or health record, the difference being is that the app is completely controlled by the physicians, they can customize and launch their own mobile App based on their practice preference and choose what functions their patients can see and use,” says Dr. Hacker.

The accompanying website is a cloud based saas application for physicians so they can instantaneously program and launch their own app. The physician can market their services and expertise with the app just like a website but can also control what interactive features they would want their patients to have including enabling their patient to easily refer the doctor to friends and contacts, plus requesting an appointment, cancelling an appointment, requesting lab results, medication refills, newsletter registrations, and signing up for research studies among many others. The physician can seamlessly create their own storefront where patients can purchase the products that they already retail in their office.

“One of the most powerful features is the ability for the physician to send ‘Instant Broadcasts' and in real time alert patients to service and product offerings, this is much more effective and instantaneous than traditional email, “ says Dr. Hacker.

AppForMyPatients has databased detailed information on thousands of cosmeceutical brands and products to enable one click addition of the product to the physician's storefront. “This functionality is unique in that it would typically cost a physician thousands of dollars to have a app for their practice with this sort of custom development, not to mention the time it takes to build one yet we offer the service at $19.99 per month for solo practitioners, with no contracts, and no penalties for cancellations, so doctors can fearlessly create their own App without the burdensome costs of typical contracts and software,” maintains Dr. Hacker. “Plus patients can be reminded to reorder products and can receive ‘instant broadcasts' from physicians announcing certain service or product offerings. All of this performed in a HIPAA compliant mobile environment.”

Cynosure Receives Expanded FDA Clearance to Market PicoSure for Treatment of Wrinkles

Cynosure, Inc. has received FDA 510(k) clearance to market its PicoSure Picosecond Laser Workstation for the treatment of wrinkles with the company's new disposable energy delivery system, the FOCUS lens array. In the fourth quarter of 2012, PicoSure recieved FDA clearance for the removal of tattoos and benign pigmented lesions.

“This clearance complements our recently received approval to market PicoSure for the treatment of acne scars, and demonstrates the breadth of our FOCUS lens array technology to address additional high-volume indications,” said Cynosure Chairman and Chief Executive Officer Michael Davin. “According to the independent industry research and analysis firm Medical Insight, worldwide sales for skin rejuvenation platforms are projected to grow at a compound annual growth rate of 8.2 percent through 2018 to $512.6 million. We believe this large addressable market represents a significant growth opportunity for Cynosure and provides another avenue to drive our disposables revenue.”

AAFPRS Celebrates 20 Years of FACE TO FACE: The National Domestic Violence Project

FACE TO FACE will commemorate the 20-year anniversary of helping women regain control of their lives this October. FACE TO FACE is a humanitarian program that offers pro bono facial plastic and reconstructive surgery to domestic violence survivors to repair injuries on the face, head and neck caused by an intimate partner or spouse.

Over five million women a year are affected by domestic violence in the US, with one million requiring medical attention. Domestic violence is a harrowing experience for survivors. Scars and physical damage can remain long after the relationship has ended.

“As we reach our monumental 20th anniversary we look back on how the FACE TO FACE program has made such an enormous impact on so many lives,” says Dr. Stephen S. Park, president of the AAFPRS. “We are here as physicians to help women repair these devastating physical and psychological scars. At the same time, we're honored to have the opportunity to treat exceptional and brave women.”

Karen, a 49-year-old Florida mother and grandmother endured broken ribs, broken fingers, a concussion and damage to her nose at the hands of her abuser. She received a rhinoplasty so she could breathe again through her nose. She also says this helped her regain confidence. “I want other women to know they're not alone. Today, I'm finally happy with me,” she says.

The FACE TO FACE program aims to change the lives of women and encourage them to empower their own lives and free themselves from harmful situations to go on to live successful, happy lives. The physicians who have participated in the program have helped more than 2,500 women since its inception in 1995.

The AAFPRS works hand-in-hand with shelters nationwide to ensure the individual is counseled emotionally, has contacted a domestic violence shelter, and is safely away from the violent relationship. Once the individual has begun the inner healing process, they will be referred to a surgeon.

“The AAFPRS surgeons donate their time and expertise to treat one face at a time and one person at a time. We want domestic abuse survivors to know that there are resources available to them to seek help, rebuild their self-esteem, and take back control of their lives,” says Dr. J. Charles Finn, chair of the FACE TO FACE Committee.

The FACE TO FACE National Domestic Violence Project hotline is 800-842-4546.

RESEARCH BRIEFS: SIGNIFICANT WEIGHT LOSS INCREASES RISK OF COMPLICATIONS IN BODY-SHAPING SURGERY

Patients who lost more than 100 pounds and those who shed weight through bariatric surgery had the highest risk of complications from later surgical procedures to reshape their leaner bodies, a new study from researchers at UT Southwestern Medical Center shows.

The study compared surgical complication outcomes for 450 patients who underwent body contouring. Of the 450 study participants, 124 lost 50 pounds or more before their surgery. Patients included men and women in all age groups who completed body contouring procedures including body lifts, tummy tucks, thighplasty, arm lifts, breast lifts, breast reduction, and liposuction. Dr. Jeffrey Kenkel, Professor and Acting Chairman of Plastic Surgery at UT Southwestern and colleagues conducted statistical analyses to identify risk factors and to determine the probability of patients experiencing healing issues or complications after their surgery.

Massive weight loss status was a significant predictor of wound problems (OR, 2.69; P < .001). Patients with 50 to 100 lbs of weight loss did not have a significantly increased risk of wound problems (OR, 1.93; P = .085), while patients with over 100 lbs of weight loss did (OR, 3.98; P < .001). Gastric bypass (OR, 3.01; P = <.001) had a higher risk correlation than did diet and exercise (OR, 2.72, P = .023) or restrictive bariatric surgery (OR, 2.31; P = .038) as a weight loss method.

With these considerations in mind, Dr. Kenkel investigated physiological factors that make massive weight loss patients susceptible to complications, such as infection, delayed healing, ruptures, and reddening of the skin.

One reason why post-bariatric patients have more complications is nutrition. Following bariatric procedures, many patients consume less than 1,000 calories daily, which leads to lower protein levels and nutritional deficiencies. Their bodies adapt to their new nutritional state, which then changes when the body becomes stressed by surgery.

“It is imperative that patients account for their dietary deficiencies and prepare their bodies for surgery,” said Dr. Kenkel, Director of the Clinical Center for Cosmetic Laser Treatment and Chief of Plastic Surgery at UT Southwestern University Hospitals. “Nutrition plays an important role in skin healing, collagen production, and the generation of new blood vessels, all of which are important during recovery.”

To improve patient health, UT Southwestern plastic surgeons currently conduct nutritional assessments and administer protein and vitamin supplements.

“Surgeons should monitor these patients carefully and make sure their vitamin and protein supplements are complete. Daily protein supplements are vital for achieving complication rates that are in line with non-bariatric candidates,” Dr. Kenkel said. “We can also enhance recovery by tailoring pre-operative care to the patient's weight loss amount and method. As our understanding of these risks advances, we are able to provide the growing number of body contouring patients the best possible circumstances for a safe recovery.”
—Aesthet Surg J. 2014 May 1

RESEARCH BRIEFS: FACIAL PLASTIC SURGERY CAN SAFELY ADDRESS THE MAJOR ASPECTS OF AGING IN ONE OPERATION

A total facial rejuvenation that combines three procedures to address the multiple signs of an aging face and neck can be performed safely at one time, according to results of a new study. Total facial rejuvenation, which combines an extensive facelift to tighten skin and muscle, specialized, midface implants to restore fullness< and laser resurfacing to reduce skin's irregular texture and discoloration, can be safely performed at one time, reports corresponding author Dr. Achih H. Chen, facial plastic surgeon in The American Journal of Cosmetic Surgery.

According to Dr. Chen, Director of Facial Plastic and Reconstructive Surgery at the Medical College of Georgia at Georgia Regents University and Director of The Georgia Center for Facial Plastic Surgery in Evans, GA, surgeons have been concerned that, while simultaneously addressing the major signs of an aging face and neck might give patients the improvements they want in one down-time, trauma to surface and underlying tissues might result in skin loss and other problems.

However, a retrospective review of patients undergoing combined extended-SMAS rhytidectomy, mid-face augmentation, and full-face erbium:YAG laser resurfacing by a single surgeon showed patients experienced normal wound healing, producing a new top layer of skin and wearing makeup again within two weeks. All patients included in the retrospective review were female and aged from 58 to 71 years. There were no cases of flap necrosis or slough. There was one case of hematoma that resolved with conservative management. One patient with a history of Roux-en-Y gastric bypass had an implant infection. She was found to have malabsorption of her antibiotics, which immediately resolved once her antibiotics were crushed. Epithelization occurred within 10 days, and all patients were able to wear makeup after 10 days. The authors noted that none of these complications were felt to be the result of combining the procedures. They concluded that simultaneous extended-SMAS rhytidectomy, mid-face augmentation, and full-face erbium:YAG resurfacing is a safe and effective strategy in providing facial rejuvenation.

“In a quest for a more complete or total facial rejuvenation, we started pushing the envelope a little bit and have found that combining techniques is a really safe approach,” said Dr. Chen, noting that continued refinement of laser technology and surgical technique enabled the momentum.
—American Journal of Cosmetic Surgery; 2014. Sept.

FDA Accepts Investigational New Drug Application for Alphaeon's Neurotoxin Evosyal

The FDA accepted the Investigational New Drug (IND) Application to conduct clinical studies for EVOSYAL, a botulinum toxin Type A neurotoxin that was acquired by Alphaeon last year as part of the acquisition of Evolus Inc.

“The product development team is very pleased that the research presented in the IND application was accepted by the FDA without questions, permitting the initiation of the clinical study to support safety and efficacy of this excellent product,” said Del Stagg, PhD, Alphaeon VP of Regulatory.

“Evosyal represents the state-of-the-art in both consistent manufacturability and potency as a 900 kDa neurotoxin molecular complex with high purity, both of which we believe will aid in achieving precise, predictable and long-lasting patient outcomes,” said John Gross, MD, Chief Scientific Officer for Evolus.

“FDA acceptance of our IND and clinical program is a critical milestone towards FDA approval and a testament to the strength of Alphaeon's clinical development team,” said Alphaeon Beauty President, J. Christopher Marmo PhD. “This approval is a key step in bringing U.S. consumers new best-inclass aesthetic products.”

According to the ASPS, botulinum toxin Type A was injected for cosmetic purposes more than 6 million times last year, accounting for over $2 billion of consumer spend annually, which was a three percent increase from the previous year.

Alphaeon says it expects the initial clinical trial to be fully enrolled by the end of 2014.

Cynosure Acquires Assets of Ellman International, Inc.

Cynosure, Inc. has acquired the assets of Ellman International, Inc. for approximately $13.2 million in cash. In addition, Cynosure assumed certain contractual and current liabilities associated with normal working capital. Based in Hicksville, NY, Ellman develops, manufactures and markets advanced radiofrequency (RF) technology for precision surgical and aesthetic procedures and offers a line of aesthetic lasers. Ellman's current annualized revenue run-rate is approximately $25 million. The transaction is expected to be accretive to Cynosure's earnings per share by the first quarter of 2015.

“This transaction complements our brand portfolio, expands our market opportunities and enhances our recurring revenue stream,” said Cynosure Chairman and Chief Executive Officer Michael Davin. “Ellman combines a 55-year history of innovation with an outstanding reputation for developing high-quality products that serve the needs of a global customer base. Thousands of physicians, cosmetic surgeons and medical aestheticians rely on Ellman technology.

“We believe these assets are an excellent strategic fit for Cynosure. Ellman's RF product line broadens our technology platform, while its aesthetic lasers allow us to offer a value solution at a different price point than our current offerings. We are pleased to welcome the talented Ellman team to the Cynosure family.”

The Ellman product line includes the Surgitron and the RF-based Pelleve Wrinkle Reduction System among others. Pelleve is a skin tightening system for non-ablative skin rejuvenation that can be performed in an hour or less, is pain free, and is associated with no downtime for the patient. In February 2014, Ellman announced that its PelleFirm RF Body Treatment System had received US Food and Drug Administration clearance for tissue heating and the temporary reduction in the appearance of cellulite. The device also is CE Marked for use as body skin tightening and cellulite reduction procedures.

Ellman has approximately 100 employees, including an 18-person direct sales force in North America, a research and development team and distribution managers who oversee more than 65 international distributors. Cynosure expects to retain substantially all of the employees at Ellman, which becomes a division of the Company.

In other company news, Cynosure announced the promotion of Chris Aronson to Vice President of North American Sales. Mr. Aronson, previously Cynosure's Eastern Area Director of Sales, will be responsible for managing the Company's North American direct distribution channel and expanding customer relationships throughout the region. He will report to Doug Delaney, Executive Vice President of Worldwide Sales.

Alphaeon to Acquire Clarion Medical Technologies

Alphaeon Corporation, a subsidiary of Strathspey Crown Holdings LLC, and Clarion Medical Technologies Inc. have entered into a definitive agreement for Alphaeon to acquire all of the outstanding shares and assets of Clarion, a provider of medical and aesthetic equipment and consumables in Canada, for an undisclosed sum.