Pssst, hey you. I have a secret. I can't tell you right now because my source said I could not say anything. Well thanks for listening to nothing. Carry on.
Renasys recall
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Pssst, hey you. I have a secret. I can't tell you right now because my source said I could not say anything. Well thanks for listening to nothing. Carry on.
FDA will under no circumstance give information on dates in advance. This is someone getting drunk on Cafepharma and trying to motivate people to stay. You are the same one who has posted previously that this would only take a week and then it will be resolved within one month. Francis did not send a letter to our customers if they knew it would be resolved late in the month. He even said that in the letter it would take longer than expected. Plus we have sent a letter saying supplies are gone by end of month. If we tell our hospitals don't worry and they get left high and dry you will never be able to set foot in that facility again. What a bunch of BS by a S&N homer tried and true. Credit for your loyalty but not for lying. If you are so sure tell us how you found out...no names needed but you sound like a kid on your post the way you spelled it out
C'mon Who really doesn't have a resume out?
I deleted mine. S&N till the end! Go big orange!
Blind, careless, and otherwise ignorant zeal will get you nowhere, my friend.
Talked to a recruiter and they said that they know someone at Medtronic's HR high up and they dont want S&N NPWT division. If/when merger happens, division will be eliminated if FDA is not cleared up and if it is will be sold to venture capitalist. There may not be much to sell to a VC even if it is cleared up. Strong suggestion to get resume ready.
Wow, this page has been SUPER quiet. CRICKETS!!! Hello, hello, hello, hello? Echo, echo, echo! You fucktards are hilarious. Long live KCI! We control the market. We can walk in to a hospital and tell everyone to go fuck themselves and they will respond with "yessir, may I have another?" LOLOL!!!! Good riddance, S&N!!!!
I procrastinated getting my resume polished only to here from a recruiter that there are now a lot AWD resumes already in circulation in his database. I asked what is a lot, didn't get a number. He noted it is much less expensive for a company to give severance packages when the first big wave leaves on their own so they wait several weeks after debacle like this. I never thought of that. The first jumpers fill all the good openings in the market. Sticking around may bode well for getting a severance but leaves you with less desirable job opportunities. Decisions, decisions....
That very same scenario happened at my bros division of HP , the company saved a small fortune by waiting till 40% of the engineering dept. left voluntarily.
Keep telling yourself that if it makes you feel better. As a KCI rep, I've been welcomed back into the only facility I lost to S&N with open arms and cheers. During a week of floor to floor inservicing, not a single RN or doc has had anything positive to say about your little NPWT offering. Even the apparent lack of clinical knowledge of the rep was a constant source of laughter. But take comfort in knowing that even though Renasys was a crap product and the rep's clinical knowledge was nonexistent, your stuff is cheap! Or was....
I would tell you to shove a Pico where the sun doesn't shine, but that's too small to be painful enough.
At least were all getting paid pretty well for staying home and looking for new jobs.
^^^ This KCI guy. You know what you should do? Write a sob story letter to the FDA.
NO FAIR!
It's not a sob story, it's a tactical business move to remind the FDA that we at KCI have done all the right things. Imagine if the shoe were on the other foot and KCI was the company who got the letter about misbranded products and were allowed to keep selling VACs? Smith & Nephew would be crying, "KCI pays off the FDA and they can do whatever they want."
Per the most recent UHS quarterly report ...
http://www.sec.gov/Archives/edgar/data/886171/000110465914061079/a14-13925_110q.htm
17. Subsequent Events
In June 2014, Smith & Nephew announced that it had ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy (“NPWT”) product line in the United States following a request from the FDA to obtain additional regulatory clearances through the premarket notification 510(k) process with respect to certain design modifications made to the RENASYS product line. Subsequently, the FDA authorized limited distribution by Smith & Nephew of these products under a Certificate of Medical Necessity (“CMN”) program. The Company is unable to predict when or whether Smith & Nephew will resume full commercial distribution of the RENASYS product line but it has been informed by Smith & Nephew that the 510(k) clearances for these products will take at least three months and probably longer, and that Smith & Nephew is requesting that customers using a CMN transition to alternative NPWT providers by no later than August 31, 2014. The RENASYS product line generated approximately $24 million in annual revenue for the prior twelve month period from device rental ($14 million) and disposable sales ($10 million) which was included in our MES segment. The net book value of the equipment approximates $5 million as of the end of June 2014. The Company is working with our customers to provide alternative solutions. In late July, the Company signed an agreement with a NPWT manufacturer to provide an alternative solution to our customers, and we have already secured over $1 million in annualized rental revenue contracts with our customers. However, some of our customers have met, or may in the future seek to meet, their NPWT needs directly with other manufacturers or service providers. The Company’s future financial results will be negatively impacted by the interruption of commercial distribution of the RENASYS product line and we anticipate losing the majority of the disposable portion of our revenue based on the new agreement with an alternative NPWT manufacturer. The gross margin on the disposable portion of the business is significantly lower than the overall MES segment gross margin. The potential impact will be highly dependent upon the outcome of the factors mentioned above. The Company is currently assessing the financial impact to our business and, while highly sensitive to the outcome of the above factors, the Company estimates the net loss in revenue at $5 to $10 million for the balance of 2014.
OK, so what's the latest on the FDA thing with Renasys? Are they also having problems with the Biotherapeutics line (oasis, santyl, etc)? Haven't heard anything, but haven't seen any Renasys either, with the exception of course of CMN product that seems to be flowing freely.
How's that resume coming along? Stop spreading gossip, 99% of the people knew you were lying but those other 1% made fools of themselves going in to hospitals
Thank you. You are a jerk. I was told this would be cleared up by a reliabe source but obviously there is a lot of gossip and incorrect infromation going around right now. Yes, I would agreee that this has completely crippled our business and it is time to move away from S&N but I did not post that message with the intention of lying and putting peoples reputations at stake. I am truly sorry and yes I am as disguted with S&N as everyone else. We were told a bunch of lies about the future and they obiously were not true.
Well.....it's 8/28/2014. I guess it's "business as usual" now.
Yeah, if "usual" means we don't have a product to sell because we didn't get the regulatory documentation right.
Thanks for this outlook Little Miss Sunshine.