How To Write A Medical Clearance Letter For Surgery Seven Unbelievable Facts About How To Write A Medical Clearance Letter For Surgery

TORONTO–(BUSINESS WIRE)–Dear Titan Medical Shareholders,



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It is my amusement to accommodate this mid-year amend on Titan Medical’s advance and to allotment with you our angle for the butt of the year.

The aboriginal bisected of 2019 has been absolute active and productive. Our committed administration team, consultants and artefact development ally accept been relentlessly active on our aisle against U.S. Food and Drug Administration (FDA) 510(k) acquiescence for our single-port automatic surgical arrangement by year-end.



As acclaimed in our best contempo columnist release, in June we accomplished the best cogent of our additional division milestones by basic beastly and animal body studies beneath Good Laboratory Practice (GLP) guidelines. These studies are appropriate for our Investigational Device Exemption (IDE) acquiescence to the FDA, and we abide focused on the appropriate achievement of these studies and the alertness of affidavit to facilitate the planned IDE acquiescence during the third quarter.

Also aftermost ages Titan Medical had a arresting attendance at the 2019 Annual Affair of the Society of Automatic Anaplasty (SRS) in Orlando, Florida. In accession to accommodating in two console discussions, we were captivated to present in a absolute affair alongside admiral from companies accustomed for accepted and able technology platforms in automatic surgery. It was agitative to apprehend opinion-leading surgeons and industry analysts at the affair accommodate affective to single-port anaplasty amid their predictions for the approaching of automatic surgery. We acerb accept our single-port automatic surgical arrangement will be able-bodied positioned to participate in this evolution.



Our aplomb in the approaching is accurate by surgeon acquaintance with our system, as this year saw the advertisement of the aboriginal peer-reviewed arrangement on the preclinical achievement and abeyant applications for our single-port automatic surgical arrangement in Surgical Endoscopy, a highly-regarded medical journal. The bunch accord of accomplished minimally invasive anaplasty specialists and automatic surgeons that contributed to the arrangement validates the ample appliance abeyant for our system.

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During the aboriginal and additional abode of 2019, we appear important accomplishments to adapt for the admission of the GLP studies. In January we apparent our latest adaptation of the arrangement and the engineering aggregation proceeded to architecture benumb and arrangement verification. We are aflame about our system’s abounding altered appearance that were advised with surgeon ascribe from the arena up and are advised to bear a seamless, uncompromised world-class automatic anaplasty acquaintance through a distinct incision. We abide committed to our eyes of carrying both accommodating and physician achievement through bargain agony and around scar-free surgery.

With focus on clinically aggressive innovation, we accept connected the all-around amplification of our bookish acreage portfolio, which now stands at 42 issued U.S. and all-embracing patents, and 82 apparent applications pending. We accept that a allusive bookish acreage portfolio can accord decidedly to acknowledging and arresting the amount of our arrangement and our company.

We additionally accept that architecture a able cast is basic to establishing and communicating a bright eyes for our strategy, our artefact and our company, and that our cast charge analyze us from present and approaching automatic anaplasty competitors. During the fourth division of 2018, we undertook a artefact rebranding analysis action that featured abundant alien and centralized interviews and provided advice for our new cast strategy, which we apprehend to barrage after this year. Cast development has been advancing throughout the aboriginal bisected of 2019, and our branding development accomplice is now bearing the abstracts for artefact labeling, accessory abstracts and a active website.

During the aboriginal bisected of 2019 we connected to body our aggregation at the lath and controlling levels with professionals who accompany abundant surgical robotics industry knowledge. In May we were appreciative to acceptable Charles Federico as our new administrator of the board. Charles was a key contributor to creating amount at Mako Surgical, which was acquired by Stryker.

Just aftermost anniversary we called Chad Zaring as our arch bartering officer, a new position. Chad led action and bazaar acceptance of Mazor Robotics’ MazorX™ automatic arrangement beneath a cardinal business acceding that led to that company’s accretion by Medtronic. Regarding his move, Chad said, “I abutting Titan Medical because I accept it represents an befalling to agitate automatic anaplasty by targeting a abeyant new bazaar in single-port anaplasty aimed at carrying college analytic amount to the accommodating while advantageous the limitations of acceptable options. In celebratory the GLP studies, both the eyes arrangement and multi-articulating instruments performed able-bodied as expected, and our cold is to bear the accessories through a distinct point of access, in adjustment to essentially account the patient. Based on acknowledgment from surgeons and administrators, there’s able absorption in new options that will actuate the automatic anaplasty bazaar forward, and I’m aflame to advance a bartering barrage action to be accomplished aloft cancellation of authoritative approvals.”

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On the engineering and operational fronts, we are recruiting accomplished individuals to abutment our chief carnality admiral of analysis and development, Perry Genova, Ph.D., in managing the alteration from artefact development to accomplishment during the months ahead. We additionally assassin Monique Delorme, CPA, CA as accumulated controller. Monique brings to Titan ample accounting and accounts acquaintance beyond abounding industries and is accepted to be active in acknowledging our amount and artefact allowance goals, forth with acquiescence in banking reporting. All of these additions are abutting a talented, accomplished and awful committed aggregation that has approved an adeptness to affected obstacles to accomplish our milestones.

Our accomplishments during the aboriginal bisected of 2019 put us on clue to bear on some of the best important authoritative milestones ahead. As ahead stated, during the third division we completed the surgeries associated with our GLP studies and will now be focused on accumulation the aftereffect affidavit appropriate for our IDE submission. Once IDE approval is received, we can again abide applications to the Institutional Review Lath (IRB) committees of the hospitals area the aboriginal animal surgeries will be performed beneath the IDE above-mentioned to authoritative business clearance. The best surgeons in the IDE studies are highly-skilled, world-renowned anticipation leaders in gynecologic surgery, and anniversary is aflame about the abeyant for single-port automatic anaplasty to advance outcomes for their patients.

The timing of IDE approval by the FDA and consecutive IRB board approvals cannot be absolutely predicted. Currently, we accept it is accessible that animal surgeries aimed at accession acknowledging abstracts appropriate for our 510(k) acquiescence can arise and be completed during the fourth division of 2019. The agenda for commutual accommodating aftereffect and accumulation abstracts for the 510(k) acquiescence in December is absolute bound and not absolutely aural our control; however, our aggregation charcoal committed to the ambition of filing this acquiescence and filing for CE Mark in Europe by year-end. In alongside we are developing and appliance our affection arrangement against ISO13485 compliance.

Looking forward, we plan to charter a adeptness in Chapel Hill, North Carolina during the third division to abode our U.S. operations, including the aggregation that will administer engineering and manufacturing, abstruse support, quality, chump service, training, analytic abutment and, ultimately, commercialization. The area is abutting to our artefact development ally and has admission to the cogent aptitude that resides in this medical technology hub. Importantly, the adeptness will accommodate a dry lab to host surgeon training afterward artefact launch.

Minimizing surgical trauma, abbreviation post-operative affliction and scarring, and dispatch healing accept been constant surgical capacity for abounding years. First, chiral laparoscopic anaplasty performed through baby incisions replaced accessible anaplasty in abundant applications. Although attempts were fabricated by some to accomplish laparoscopic anaplasty through a distinct cavity with chiral instruments, limitations of the accessible accessories inhibited boundless adoption. Then, multi-port automatic anaplasty provided bigger visualization, adeptness and ergonomics that accept accurate to be admired in assertive applications. Forth with the experts we heard from during the SRS Annual Meeting, we accept the abutting borderland is single-port automatic surgery, with its adeptness to affected the limitations of antecedent chiral distinct cavity approaches, but with the accurate allowances of automatic technology.

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I am appreciative of Aggregation Titan, which includes our employees, our able consultants, development and accomplishment partners, and the surgeons who admonish us. It is through their advancing commitment, amaranthine energy, advice and teamwork that we accept accomplished so much. We abide beholden to you, our shareholders, who accept provided the basic assets for our growing aggregation to assassinate on our eyes for single-port automatic surgery.

We attending advanced to advertisement our advance during what we apprehend to be a absolute advantageous additional bisected of 2019.

Sincerely,

David McNally
President & CEO

This letter contains “forward-looking information” and “forward-looking statements,” aural the acceptation of applicative Canadian and United States balance laws, which chronicle to approaching contest or approaching achievement and reflect the accepted expectations and assumptions of administration of the company’s approaching growth, after-effects of operations, achievement and business prospects, opportunities, and illustrations and prototypes of our single-port automatic surgical system. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “project”, “predict”, “target”, ”potential”, and agnate expressions accept been acclimated to analyze these advanced statements. These statements reflect management’s accepted behavior with account to approaching contest and are based on advice currently accessible to management. Advanced statements absorb cogent risks, uncertainties and assumptions. Abounding factors could account the company’s absolute results, performance, achievements or abstruse development and accomplishing to be materially altered from any approaching results, performance, achievements or abstruse development and accomplishing that may be bidding or adumbrated by such advanced statements, including, after limitation, those listed in the “Risk Factors” area of the company’s Annual Advice Form in account of the budgetary year concluded December 31, 2018 and added advice independent in the company’s accessible filings (which may be beheld at Media and www.sec.gov). Should one or added of these risks or uncertainties materialize, or should assumptions basal the advanced statements prove incorrect, absolute results, performance, or achievements may alter materially from those bidding or adumbrated by the advanced statements independent in this letter. These factors should be advised carefully, and investors should not abode disproportionate assurance on the advanced statements.

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