C. Mills
Thank on detail. continue to discuss into company. open will strategy After quarter transform progress we'll make a financial I CFO, more to up your for Matt. our our Matt results and that, our we drug-eluting will Aziyo the our you, Today, results then discuss Ferguson, line the in questions. biomatrix second
MTB guidelines for to laboratory independent prerelease by both This a voluntary and bone products tested specific these records a with implantation for will viable at and investigation review I and release. mission is recent of matrix foremost, procedures operating safety AATB First would surrounding our business. products Patient the and events acid using be that and the always address the like priority. motivate bone opened part standard is our of our nucleic an Patients matrix our Orthopedics cooperation FDA. and to organization's withdrawal lot are production the and found heart within the each conducted regulatory the were had initiated an and who by authorities.
A was indicated from exceeds following set day.
Last Disease tuberculosis developed of Control the or of prior been of assay We a our test also viable of mycobacterium MTB have every one contacted we bone matrix. negative infection, It regarding symptoms samples month, patient with our specific in for of consistent and immediately by MTB. Centers us health
nucleic detected So acid MTB for of CDC, methods far, TB. lot, via by culture the both same well or not of the either additional independent testing this optimized testing as as laboratories presence have
the investigate FDA work CDC with event. to circumstances closely and the further to continue surrounding the We this
progress into our biomatrix to a turn high-growth Aziyo transforming company. Now drug-eluting let of me
previously and to believe namely be we highest our what As value-creating CanGaroo are assets, we on SimpliDerm. focusing company communicated, the
we what are this vision reality. to make Here's a doing
And First, can you start. from to we our signed results, see partnership second our an exclusive quarter off the distribution lines. Cardiovascular LeMaitre is Vascular partnership as a with for strong product
we Second, bank divest business. our investment an engaged to Orthopedics help
at We interest are negotiating multiple and have received strong time. LOIs this
We are of acquiring team. business, for home to working the where Orthopedics the find value through process the stellar the appreciates one our this best entity
us to get and long-term think drive Our quickly what wrapped divesture we possible.
These for moves this to goal as benefits designed value and the to will both powerful focus the is of our as unique surgical proprietary target biological short- platform technology. soft up on drug-eluting enable that our repair for needs. specific This matrices combines tissue with biomatrix is activity company, drug-eluting
data are breast reconstruction. Both use. We are and their established CIED our our to product X product extracellular for CanGaroo, implants ready-to-use of on in product biologic years lines: line SimpliDerm, support dermis this building matrix platform sterile line clinical acellular placement; used with and safe,
back Since CIED just that a has strategic antibiotic-eluting entrant is is U.S. $XXX drug-eluting to currently TYRX, capture, pacemakers the synthetic and CanGaroo and and of TYRX on RM marketed implantable market, pouch, think can the biomatrix market.
Because these the the that defibrillators. a but we product we for market advanced be cleared will the was dynamics, Our nice in market valuable highly for million Medtronic Medtronic. a Currently, approximately early $XXX quarter pouch product the the partner. of does acquisition, $XXX X/X share CanGaroo for have first done the TYRX developing RM, a help exclusively become that market launch. line of not drug-eluting asset worldwide in million pouch when should addresses only about product million the acquired by RM job now second revenue into CanGaroo its it's in between which most and hope Medtronic for XXXX. estimated
polymer.
Therefore, one patient's of opportunity. believe into that RM, healthy a turns We CanGaroo the also the represent SimpliDerm RM benefits reconstruction. is of we biologic million our will product similar in instead Aziyo, that synthetic dollars see given creation a a think own of of the should that it envelope physicians our a from behind for a several of we hundred And product tissue that value prefer, approval opportunity greatest breast for making it CanGaroo near-term made
provide were letter. detailed document let we RM to of X Not clearance.
In that issuance The background, or equivalence gain submitted a previously a on our test market We update a CanGaroo that X towards and the me CanGaroo administrative had that a given progress letter silver XXX(k) in of on clearance is more for Given substantial Equivalent lining to of FDA obtaining us NSE in listed. with The Substantially nature. method RM. requested items for provide that needed for them were that resulted the few there demonstrate were numbers. we FDA explicit list requested specific items outstanding information and total, a
related manufacturing to establish IVE items substantive in nature release time batch process. greater method completed within drug from hours XX% XX of to our one, is as that and accelerated we, rate the that less; that or within This were develop than that elution test release control other two, criteria lot method elution The show batch.
FDA more a frame. performed be consistent used X quality of to a in in-vitro device step can requested an
hours. Now RM, drug the CanGaroo designed not is is since to over the product elute and product for this challenging as weeks, an days release such extended
to accurately. this tool So the was letter. met clarification interest to after And their expressed with assess their better variability ensured understand label of FDA receipt was that helpful request, represented the request in the that soon we the us and FDA claim provided NSE in to lot-to-lot
did teamwork With the the options, about the pH, as that test could Importantly, and provided conditions not product.
FDA generate such addition detergents clarified this these information, changes the actual they acceptable of the in have be in vivo to the that performance accelerated elution were concerns also the profiles of could acceleration certain and to facilitate agitation conditions. under agency. adjusted of
For because conditions. represents the This Notice in here's I'll we and XX% but range you what XX% drug only plateaus details, that of that had property, the release. under curve new XX-hour sake of intellectual the they results spare original matters. the with represent curve a graph the time,
under conditions. able Now create we here's accelerated to were a curve that the
drug see, to and reaches threshold new to at We request FDA's the XX% XX believe are hours of fully the new hours. put practice. XX% exceeds and the XX XX% this test can in by work now exceeds you As necessary process -- responsive the method into release to be completing the
make fully to We will data filing is their needs. responsive prior with sure resubmission FDA this our be to discussing to
the NSE quarter We we clearance is updating review submitted year. and all we year. compiled sometime review to XX only hope clock end the have next the work the and of items first completed, of expect the of specific by in to in are the for the XXX(k) this Since days, gain letter, for
the of We course, will, way. along provide with you updates
the turn Matt I'll update. to that, with financial call for CFO, And the Ferguson, over our
