Men´s Health devices

1. Medical Device Industry

Andromedical’s products are classified within the so-called medical device industry. A Medical Device is any instrument, device, material or any other article intended for human use for the diagnosis, prevention, treatment or cure of any illness.

The medical device industry is growing steadily at 5-8% a year. The total market was US$330 billion in 2014. Mega-mergers are creating fewer larger players. The USA is the largest medical device market with +7,000 companies. European Union is second with +7,000 companies and China is third with +13,500 companies. Most of them are SMEs which have fewer than 50 employees. In the USA and Europe, 400,000 individuals are directly employed in each geographic area, and 2MM are indirectly employed.

The health expenditure per capita is $9,146/year in the USA and $3,458/year in Europe. Each European spends on average more than 120 Euro in medical technology. The sales focus is shifting to growth markets because of its large population, growing middle class and improving healthcare systems.

The 30 of the largest global device and diagnostic equipment companies have the 74% of sales. Johnson and Johnson, GE and Medtronic are the top 3 medical device companies. Diagnostic imaging devices have a 40% market share. Cost containments, pricing and reimbursement controls, and regulatory issues are key drivers for the sector.

The current trends in the medical device industry are M&A processes, wide products range, R&D investments, new markets, cost-saving strategies, outsourcing, remote monitoring, big data analysis, mobile health, robotic surgery, medtech-pharma and Google player.

The global medical devices market is expected to reach $543.9 billion by 2020 driven by an aging population, increasing healthcare expenditure and technology advancements.

2. Urology Device Industry

The urology device industry includes 8 key markets: urinary incontinence device, stone management device, BPH treatment device, urological endoscope, prostate cancer treatment device, urodynamic equipment, nephrostomy device and erectile dysfunction device. Over 3 million procedures using a urology device were conducted in 2013.

Now Boston Scientific dominates the Urological Device Market in the U.S., after the acquisition of American Medical Systems, with their significant market share of benign prostate hyperplasia (BPH) treatment devices. C.R. Bard is in second position and leads the urinary incontinence device market. Olympus is expected to continue their lead in the urological endoscopes segment. Other leading competitors in these markets are Coloplast, Karl Storz and Covidien.

Players driving the European urological device market are Coloplast, a prominent player in the markets for nephrostomy devices, urinary incontinence slings, stone treatment devices and erectile dysfunction devices as well as Wellspect HealthCare, Teleflex, C. R. Bard and Olympus.

The current trends in the Urology device industry are market expansion, M&A acquisitions, an aging population, technological advances, new markets with a large population, lowering costs while raising quality, robotic surgery, reimbursement controls and regulatory issues.

The urology devices market is expected to reach over $3 billion in the USA and over $2 billion in Europe by 2020, driven by an aging population and an increasing number of procedures. This market includes TURP devices, laser BPH devices, brachytherapy, urinary catheters, nephrostomy devices, urinary incontinence slings, stone treatment devices, urological endoscopes and erectile dysfunction devices.

3. Men´s Health Device Industry

The andrology device industry includes 4 key markets: erectile dysfunction device, peyronie´s disease device, penile lengthening device and prostate post-surgery device.

Erectile Dysfunction (ED) is estimated to affect more than 150 million men worldwide and it is expected to double in 2030. Men affected by ED are 30 MM in the US & 20 MM in Europe. The U.S. market for ED therapies (drugs, VCD, PID) is valued at +$2.5 billion in 2016. Medicare paid +$172 MM for +473,00 VED from 2006 to 2011.

The Erectile Dysfunction causes are: diabetes, cardiovascular problems, prostate disease, medications, surgery, lifestyle choices (smoking, etc), depression/anxiety and low testosterone. ED drugs have hard side-effects, such as myocardial infraction (0.4-1.2%) and cardiac death (0.05-0.3%), and 30% of men with ED don´t respond well. Vacuum constriction device (VCD) for ED has high patient satisfaction, safety profile and 90% effectiveness. Penile implant device (PID) is a surgical therapy for ED; semi-rigid and inflatable types are available. The surgery will damage the cavernous bodies and should be last option.

Peyronie´s disease prevalence is 5% of adult men. A proven Peyronie traction therapy (PTT) with Collagenase and vitamin E will be the guideline in Peyronie´s disease as a simple ambulatory treatment, without the risky surgery which is last resort.

The 30% of men worry about the size of their penis, named small penis syndrome (SPS), and patients with micropenis (<2.7”). They can use a proven penile lengthening device based on penile traction therapy to get permanent results in a few months without any side effects.

In addition, urologists recommend the penis rehab after surgery after radical prostatectomy and Peyronie´s disease surgery with an extender based on penile traction therapy (PTT) to avoid penis shortening and with a vacuum erection device (VED) for tissue oxygenation.

4.1. Penis Extender Market: Peyronie´s disease

The penis extenders market includes 3 key markets: penile traction therapy (PTT), penile lengthening device (PLD) and prostate post-surgery device.

Peyronie´s disease prevalence for adult men is 5%, and incidence in USA of 120,000 men every year. In UK there are +150,000 men with Peyronie condition, and NHS doesn´t pay the $5,000 of the implant. 47% of patients are motivated to seek PD treatment, 85% of men seek treatment within 3 months of diagnosis and the average time patients live with Peyronie´s ilness is 3.5 years.

The 67% of urologists are very knowledgeable about Peyronie´s disease, with a low satisfaction with some treatments. 1,000 urologists treat PD invasively and 7,000 urologists treat it non-invasively. Surgery is effective but has a very low acceptance due to adverse events. There is a Peyronie´s market opportunity for proven methods with no risk.

The Peyronie´s disease (PD) treatment market is based on surgery, enzimes and penile traction therapy.

The proven methods with low risks are penile traction device (PTT) and collagenase. The evidence indicates that colagenase gets a reduction of 28% of penile curvature and Penile traction device has a +50% of reduction. There is a Peyronie´s market opportunity for penile traction therapy with low risks and a lower price than collagenase injections.

American Urological Association is evaluating the good results of penile traction therapy in Peyronie´s disease in the study with Andropeyronie® which are: The mean curvature decreased from 33° at baseline to 15° at 6 months and 13° at 9 months with a mean decrease of 20° (P < 0.05) in the PTT group. VAS score for pain decreased from 5.5 to 2.5 after 6 months (P < 0.05). EF and erection hardness also improved significantly. The percentage of patients who were not able to achieve penetration decreased from 62% to 20% (P < 0.03). Penile traction therapy was associated with the disappearance of sonographic plaques in 48% of patients.

4.2. Penis Extender Market: Penile lengthening

The penile lengthening device (PLD), known as penis extender, is a safe and effective proven method based on penile traction therapy for penile dysmorphophobia or small penis syndrome (SPS), known as the “locker room syndrome”, and for patients with micropenis (<2.7”).

Mondaini says the regular penis size is 3.5 inches (9 cm) flaccid, 4.5 inches (12.5 cm) stretched and 5.9 inches (15 cm) erect. There are effective methods in the market (surgery, penile traction therapy) and ineffective methods (massages, pills). ISAPS plastic surgeons society has stated that about +15,000 penile enlargement surgeries take place in the world per year, with a cost of $13,000/surgery, but the length gain is only 1 cm. The market of penis lengthening is a huge multi-million-pound global industry. There is a market opportunity for Penile traction therapy as a safe and proven method with a lower price and better results than a risky surgery.

NHS explains the good results of Penile Traction Therapy, which are in the study with Andropenis®: After 6 months the mean gain in length was significant, meeting the goals of the effect size, at 2.3 and 1.7 cm for the flaccid and stretched penis, respectively. The EF domain scores improved significantly at the end of the study. The conclusions are: Penile extenders should be regarded as a minimally invasive and effective treatment option to elongate the penile shaft in patients seeking treatment for a short penis.

4.3. Penis Extender Market: Post-surgery

Penile shortening after radical prostatectomy (RP) and Peyronie´s disease (PD) surgery can be devastating, and an unwelcome side effect of these operations, as it is researched by Dr. Levine´s study.

• Radical prostatectomy: 68% to 71% of patients after radical prostatectomy report a mean measured decrease of 1.1 to 4 cm.
• Peyronie’s Surgery: has been associated with penile shortening in 7.3% to 90% of patients. The amount of shortening also varies as much as 5 cm.

Penis rehab after radical prostatectomy and Peyronie´s disease is recommended, with a post-surgery device, based on penile traction therapy (PTT), to avoid penis shortening and with a vacuum erection device (VED) for tissue oxygenation.

The number of prostatectomy procedures in USA was 138,000 in 2010. A booming business alongside the sobering notion that more than 2 million men in the U.S. are now prostate cancer survivors. AMS calls the space the “erectile restoration market”. AMS believes the global market is worth $1.7 billion annually, with $500 million of that in the U.S. Penile implants made by both Coloplast and AMS cost about $12,000 each. There is a radical prostatectomy market opportunity for penile traction therapy to complement the success of the prostatectomy surgeries and to optimize the good results of the expensive penile implants for Erectile Dysfunction.

BAUS, the British urological surgeons association, explains the good results of Penile traction therapy with Andropenis® which are the prevention of penis shortening after surgeries. More recently, the use of penile traction (with the Andropenis® penile extender) for four to ten hours each day, over a period of three to six months, has been used.