PDF) The nature, magnitude, and reporting compliance of device ...
PDF) The nature, magnitude, and reporting compliance of device ... | medwatch form 3500a

The Biggest Contribution Of Medwatch Form 8a To Humanity | Medwatch Form 8a

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By Anita Dushyanth

PDF) The nature, magnitude, and reporting compliance of device ..
PDF) The nature, magnitude, and reporting compliance of device .. | medwatch form 3500a
Appendix E: Adverse Event Reporting Forms | Use of Dietary ..
Appendix E: Adverse Event Reporting Forms | Use of Dietary .. | medwatch form 3500a
MedWatch - Wikipedia - medwatch form 3500a
MedWatch – Wikipedia – medwatch form 3500a | medwatch form 3500a
Dental device–associated problems: An analysis of FDA postmarket ..
Dental device–associated problems: An analysis of FDA postmarket .. | medwatch form 3500a
eSubmitter | The Continuum of Risk - medwatch form 3500a
eSubmitter | The Continuum of Risk – medwatch form 3500a | medwatch form 3500a
MAIMONIDES MEDICAL CENTER SUBJECT: Medical Equipment Failures and ..
MAIMONIDES MEDICAL CENTER SUBJECT: Medical Equipment Failures and .. | medwatch form 3500a
FDA Proposed MedWatch Changes - SAE  - medwatch form 3500a
FDA Proposed MedWatch Changes – SAE – medwatch form 3500a | medwatch form 3500a


Headquartered in Cedar Knolls, NJ, MYOS RENS Technology Inc. (MYOS) is an arising avant-garde diet and biotherapeutics company. Their business is focused on developing and commercializing comestible supplements, anatomic foods and ameliorative accessories aimed at convalescent beef bloom and function. Their flagship product, Fortetropin®, is a bioactive proteo-lipid circuitous that is developed from fertilized egg yolk application a proprietary process. MYOS accustomed apparent (U.S. Apparent No. 8,815,320 B2) advantaged “Process for Producing a Composition Absolute Active Follistatin” to awning the proprietary accomplishment of Fortetropin in August 2014 from the USPTO. The apparent is accurate through aboriginal 2033.

The science abaft Fortetropin…Fortetropin is a bioactive proteo-lipid complex. It is abandoned from fertilized egg yolk application a patented activity that preserves the assorted proteins and added bioactive molecules and their bioactivity. A preclinical abstraction of Fortetropin’s apparatus of activity approved authoritative furnishings on three important atomic signaling pathways (Myostatin pathway, mTOR alleyway and Ubiquitin pathway) that are amenable for advantageous beef growth.

MYOS’ artefact Fortetropin: In March 2017, the aing commenced sales of Fortetropin®-based accessories beneath the cast name Qurr (pronounced, “kyoor”) through their online website (www.qurr.com). Qurr accessories are accessible in two flavors (chocolate raspberry and boilerplate coconut) and in the anatomy of powders, puddings and shakes. Qurr accessories are positioned for three audible customer accumulation demographics in an accomplishment to abduction a broader audience:• “Qurr Well” supports advantageous crumbling by accretion angular muscle• “Qurr Toned” for announcement advantageous beef which can advance to a angular and bass body• “Qurr Strong” for athletes acquisitive to ability their best advancing training goals

Qurr accessories are awash anon to consumers from this armpit as able-bodied as via Amazon. Qurr accessories are advertised as low calorie, artlessly soy-free and non-GMO, with a recommended circadian dosage of 6.6g of Fortetropin. Pricing starts at $130 per amalgamation (four weeks accumulation absolute 28 alone packets) with added accumulation for account subscriptions or above quantities. Anniversary packet has 10.4g of supplement crumb that contains about 50 absolute calories and beneath than 4g of carbohydrates.

Management provided us with samples of the supplement powder. As a allotment of our assay process, we analyzed a few concrete characteristics. The arrangement of the crumb is agnate to that of breadcrumbs. Because it has a coarsely arena texture, it offers a nice brittle aftertaste back put anon in the mouth. There is no bogus blush added. The sample crumb absolutely has the balm of the acidity adumbrated on the characterization (vanilla coconut). The crumb offers a acceptable accession of bistro as is or aggregate with foods. The crumb blends able-bodied with water, yoghurt as able-bodied as milk. The stevia and abbot bake-apple abstract accord it a attenuate candied taste. The attic milk adds a bland acidity and the aftertaste is not overpowering. Despite actuality a aspartame agent, the abbot bake-apple aspartame contributes aught calories. There was no gastrointestinal ancillary aftereffect such as abdomen ache afterwards consumption.

Clinical Study: A abstraction was conducted in 2014 to investigate the furnishings of Fortetropin on ashen beef advance and backbone in resistance-trained individuals. The abstraction additionally aimed to investigate the anaic and cataic signaling furnishings of Fortetropin. 37 resistance-trained macho capacity of agnate age and physique/musculature (i.e. angular beef mass, anatomy mass, fat mass, beef thickness) were about assigned to accept one of two Fortetropin doses, 6.6g or 19.8g (given as MYO-X), or placebo. All the men followed the aforementioned training agenda for 12 weeks. Participants completed a training acceding for beef hypertrophy on one day and strength-training contest on accession day for two canicule of anniversary week. Anniversary accumulation performed the aforementioned exercises. All capacity were instructed not to absorb eggs for the continuance of the study. Participants’ backbone was adjourned application one alliteration best (1RM) lift in leg and bank columnist exercises. Capacity completed two sets of warmup activities. Following warmup, capacity were instructed to attack to echo their 1RM amount and accustomed bristles attempts to do so. Anaerobic ability was abstinent with the Monark Wingate aeon test.

Results: The participants who accustomed Fortetropin® had added angular anatomy mass, absent added fat tissue and acquired added beef accumulation than those that accustomed placebo. In addition, absorption of myostatin decreased in the claret of the participants who had acclimated Fortetropin®. There were no cogent differences empiric in after-effects of the 6.6g (1 scoop/day) accumulation against the 19.8g (3 scoops/day) group. Bank press, leg columnist and Wingate ability were acclimated to admeasurement backbone and power. The after-effects were decidedly added from baseline in all abstraction groups. No abstraction accompanying adverse contest were reported. The abstraction additionally evaluated assertive biomarkers including IFN-γ anarchic cytokine, a pro-inflammatory protein that plays a analytical role in deepening and autoimmune diseases. Excess levels of anarchic cytokines are associated with muscle-wasting diseases such as sarcopenia and cachexia. For capacity in the placebo group, no statistically cogent changes in serum levels of IFN-γ were noted. However, capacity in both accoutrements dosed with Fortetropin accomplished statistically cogent decreases (p < 0.05) in serum levels of the IFN-γ anarchic cytokine. This abstraction approved that Fortetropin has a absolute role in training-induced ashen beef adaptation.

To-date, the aing has not filed a Medwatch Anatomy 3500A (reporting all austere adverse events) with the FDA. Fortetropin has been awarded BSCG Drug Free® affidavit and accepted authoritative approval by Bloom Canada in 2015 (NPN:80061148).

Market Opportunity: In the aftermost decade, sales of vitamins and comestible supplements accept surged. While there are a deluge of accessories able beef building, weight-loss and bigger all-embracing health, best supplements abridgement accurate affirmation abetment abounding of these claims. Discerning consumers seek accurate affirmation that supports the statements fabricated by the architect back purchasing supplements . MYOS’ artefact proposes to ample this gap. Also, in abounding ache conditions, which leave the accommodating briefly non-ambulatory, muscle-building supplements can comedy an important role in recovery. Comestible supplements are accepting absorption in the pet diet area as well. It is in these spaces that MYOS intends to accretion bazaar share. MYOS’ accepted bazaar focus is in the sports and diet sector.

Marketing Strategy: Fortetropin is bogus by a audible third-party architect who is in abounding acquiescence with cGMP standards set by the FDA. Fortetropin is accessible as an over-the-counter (OTC) product. Fortetropin is a anatomic aliment awash through Qurr and Amazon sites.

In February 2014, the aggregation active an absolute administration acceding with Cenegenics for the auction of a proprietary conception of Fortetropin to their arrangement of age-management centers in the U.S. Cenegenics additionally answer Fortetropin through their association of physicians which focused on alleviative a growing citizenry of aged patients. The administration acceding with Cenegenics asleep in December 2016. However, in May 2017, the aggregation accustomed a acquirement adjustment from Cenegenics to bear added accessories to them.

In accession to MYOS’ branded products, the aggregation additionally affairs to advertise their proprietary admixture as an additive in added branded supplements. Since MYOS is attempting to access its offerings, we accept that the auction of Fortetropin as an additive in added accessories is a abundant activity to aerate their ability with little incremental sales and business spend.

Continuing their brand-awareness strategy, the aing was a sponsor at the IDEA World Convention in Las Vegas in July 2017. Anon after, they appear a affiliation with NFL Alumni beneath its bartering business arm, Pro Football Legends, in abutment of the NFL Alumni NY/NJ Chapter’s Optimal Bowl and Wellness Challenge. MYOS, which provided the participants (former NFL players and advancing veterans) with Qurr accessories during their workouts, acclaimed that they acquired admired artefact acknowledgment and alliances for approaching business opportunities.

Additionally, the aggregation showcased Fortetropin and the Qurr Line of Beef Bloom Accessories at the 2018 Arnold Sports Festival in March. The “Arnold”, which is billed as the world’s better multi-sport fettle gathering, is co-promoted by allegorical bodybuilder and blur brilliant Arnold Schwarzenegger. There were added than 200,000 attendees at this year’s event, which featured 20,000 athletes from 80 nations and over 1,000 booths of fettle equipment, accoutrement and nutrition. MYOS had a able attendance there, alms samples and appropriate EXPO discounted prices for Qurr products.

In continuing their efforts appear architecture cast acquaintance through cast partnerships, MYOS active a advocacy accord with IMG College, a assay of IMG, in November of aftermost year (2017). IMG Academy represents added than 200 colleges above multimedia rights, licensing and sponsorships. IMG is a all-around aggregation with abysmal roots in able sports. It additionally owns the Ultimate Fighting Championship (UFC). MYOS commenced business its accessories to bookish able-bodied programs. IMG serves as a administration approach for MYOS’ accessories while allowance anatomy cast visibility. We accept the abeyant to advantage IMG’s avant-garde arrangement is substantial.

ValuationDifferentiated product: While some sports and diet supplements accept a able accurate basis, abounding do not. Clinical studies accept apparent that Fortetropin increases angular beef mass, improves age-related muscle-mass reduction, triglycerides and fat mass. While the studies appear bigger achievement in rats, which was insightful, the assay conducted on athletes is abundant added compelling. Further, Fortetropin has been certified by BSCG, a gold accepted in comestible supplement and additive certification. The accepted abiding apparent for Fortetropin is set to expire alpha 2033.

The aggregation expects to advance barter shows and amusing media in the U.S. to advance Fortetropin and aerate the bazaar befalling for their product. MYOS is anticipating Cenegenics’ arrangement of clinicians as able-bodied as their cast ambassadors who are able-bodied trainers to accommodate Fortetropin into their treatment/promotion, which can advice augment sales. Eventually we ahead Fortetropin could acquisition its way into in specialty retailers including GNC and Vitamin Shoppe. In adjustment to drive antecedent uptake, MYOS affairs to coact with IMG College, a third affair sales adumbrative for the academy sports, to acquaint Fortetropin to assertive Assay I schools, able sports teams, cross-fit and added endurance-format athletes. The demographic of academy sports fan abject is diverse, adolescent (18-24 years of age) and affluent. This alcove bazaar provides a key customer admirers for MYOS.

DCF MODEL: We accept congenital a banking archetypal application a discounted banknote breeze (DCF) assay to acquire a fair amount for MYOS RENS. The firm’s primary acquirement beck comes from affairs accessories absolute Fortetropin from their afresh launched Qurr site. Sales of MYO-X in2013 was added than $3 million. It was awash through specialty retail aliment such as Vitamin Shoppe and GNC. We believe, accepting the artefact on the retail shelves could accession acquirement for MYOS as it had in the past. Acquirement generated from amplification into the age-management bazaar was decidedly academy in 2014 as compared to 2013 as a aftereffect of MYOS’ administration acceding with Cenegenics. Sales to Cenegenics accounted for ~60% of revenues in 2014. We ahead this arrangement could echo itself as MYOS accustomed a acquirement adjustment from Cenegenics to bear added accessories to them in 2017-2018. We ahead this additionally bodes able-bodied for MYOS’ advance affairs above 2018 and currently archetypal 2019 acquirement of about $3 million.

Gross allowance for Q4 2017 came in aing to 60%. Widening of gross allowance to 70% or added could appear by 2020 as aggregate and aggregate purchases increase. If MYOS commences affairs Fortetropin as an ingredient, that could accommodate incremental economies of calibration and added account gross margins.

Since the disease-specific applications are yet to be investigated, we do not accommodate them in our valuation. At this time, we accept additionally afar the abeyant acquirement from the pet diet articulation as the artefact is still beneath development. Depending on progress, this could aftereffect in upside to our accepted forecasts.

We ahead an advancing sales activity focused on architecture antecedent awareness, educating ambition audiences on the clinically-differentiated allowances of Fortetropin, eliciting antecedent acquirement and active post-adoption echo sales. Correspondingly, we apprehend costs associated with the advancing amplification of MYOS’ sales aggregation and business strategyto access incrementally. We are allegorical Op-Ex to accept an boilerplate run amount of about $3 actor over the aing brace of years. We ahead that the aing could accomplish absolute net assets as anon as 2023. The prime take-away from conversations with Mr. Mannello (CEO) was his plan to abound the business in two years’ time to actualize allusive actor value.

We absorb a abatement amount of 15% and 2% terminal advance rate. We amount MYOS at about $3.50/share. This appraisal provides added than 150% upside to the accepted trading amount of $1.25/share.

Risks: MYOS’ business archetypal focuses on business their proprietary artefact Fortetropin. As this is a new and ambiguous aspirant into the market, there is accident that acceptance could be slower than anticipated. As the protein supplement bazaar is awful burst with assorted players, bazaar access is easy, about creating artefact adverse and cast acquaintance can be arduous and expensive, which could advance to academy than accepted business expenses.


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