NovoNail

Regarding the complaint filed by *** ***:
Here at NovoNail, we strive to provide our patients with the most comprehensive, up to date treatment options available to clear up their toenail fungusAlthough we are very confident in our methods and have seen an
impressive history of improved results (over 80% effective rate and improving steadily as we continue to research our case load of over 8,nails), our methods do not work 100% of the timeWith tougher cases like *** *** nails, we do try to provide different, additional options to try every available avenue before admitting defeat.
With ***, we realized we had some limitations in treatment due to her Downs SyndromeShe was not a candidate for surgical nail avulsion or oral medicationDuring her consultation with our Physician's Assistant, ***, *** *** and *** were told that typically with a case as severe as ***, we would recommend nail avulsion- however, this was not an option in this specific instanceAccording to *** office note from the consultation:
"Chief Complaint: Thickened, discolored toenails Has been an ongoing problem for at least years and mother notes it is getting worse. Patient has Down's Syndrome and seizure disorder, mother presents with her, provides history and is planning to be the care provider States patient does not tolerate pain well and is disinclined to any procedure involving local anesthesia Notes her PCP directed her to NovoNail after he noticed her toes were getting worse at this year's routine check-up. Mother notes a dermatologist gave them a prescription for ureacin cream and a topical but she has not been faithful and is uncertain if there has been
any improvement Patient is a poor candidate for PO medications and mother is disinclined to use them. Plan: Condition and various treatment options for toenail fungus were discussed with the patient ranging from oral therapy to surgical avulsion of the nail plate methods Possible benefits and risks of each
approach were presented Patient has opted to pursue YAG treatment of affected nails after weeks ureacin pre-treatment for chemical abrasion. Discussed: Use of topicals, Steri-shoe, home care."
We could try breaking down the nails with weeks of a ureacin softening cream, then laser through the nails once they are thinned and softened by the cream *** *** decided this is what they would pursue and returned a few weeks later for treatment. The patient and her mother were told before the actual laser treatment that if *** could not tolerate the treatment (tolerate as in handle the pain, noise, etc) and the treatment could not be completed, then of course we would refund her treatment costWe never told her that we would refund the money if the treatment didn't work, as that is not part of our company policyWe know there is about a 20% chance that a treatment won't work and we let all of our patients know we have about an 80% success rate. We also have each
patient (or in this case, *** mother as guardian) sign a consent form, again stating that the laser treatment is not 100% guaranteedThe consent form is attached*** also informed the office that *** *** would prefer to continue seeing *** at subsequent visits because of *** medical history and her overall feeling more comfortable with one person who already knows her case/history instead of seeing a different provider each timeThis was the plan carried out until *** had to leave the company, at which time I took over *** care*** *** was indeed consulted after every visit and any patient can certainly request any specific provider, whether it is myself, ***, or *** ***, with absolutely no issue from the officeIf a patient does not request a specific provider, then it is more about rotation and which day they choose to come in for followups that decides who they will see*** ***, myself, and our receptionist have expressed to *** *** multiple times that it is not a problem at all if she wants to come in and have *** seen by *** *** (or our other podiatrist *** ***)
It is also important to note that *** *** did not follow our recommended protocols at homeAt the consultation, she was told to apply the ureacin cream liberally to all of *** nails every night for 2 weeks before treatment, although when she came in, she stated that she had "used ureacin about times (3-nights weekly for the last 4 weeks)" instead (according to *** note)At the initial treatment, she was given paperwork for recommended home care including NovoNail Solution (antifungal topical) twice daily and ureacin cream nightly to thickened nails and calluses, especially for the two weeks prior to next treatment in order to keep the nails thin enough for the laser to workClip and file nails as much as possible at homeAt the following visit, *** noted that “Mother admits to
NovoNail Solution following last laser treatment but stopped a couple of weeks ago when she resumed the ureacin cream nightly (which was placed on nail,
rubbed in some & then covered with a sock)Taking biotin, has Steri-shoe.” At the second treatment, she was told to use NovoNail Solution twice daily and ureacin cream three times a week, clip and file nails as much as possibleAt the third treatment, *** was no longer with NovoNail and I actually saw *** for the third and fourth treatmentsAt both treatments, *** *** stated that she was using NovoNail solution about twice a week instead of twice a day and using the cream about 2-times a week At both treatments I suggested using NovoNail solution more often, twice a day recommended but since she had a history of not
remembering to use the topical, try to use it as often as possibleContinue with the ureacin cream to keep nails softenedClip and file nails as much as
possible at homeAt the third treatment, *** nails were showing improvement. I recommended one more treatment to try to clear up the nails even though only three treatments are technically included in the original treatment plan pricingAt the fourth treatment, *** nails had not improved any more for whatever reason, so I listed out some options for *** ***I recommended coming back in for an evaluation with either *** *** or *** *** to see if we could try a new prescription topical that might give *** that bit of extra strength antifungal action to help continue her improvement we had seen at the last followup (which we would cover financially)We could also try to use the cream for a solid two weeks and relaser after some more aggressive filing and debridement with *** ***
I sent *** *** a letter in response to her request for refund stating that her request had been denied:
We at NovoNail recently reviewed your request for a refund. Our records indicate that you underwent a Laser “yag” procedure, and not the full *** *** treatment (nail removal)The *** *** is the only procedure for which NovoNail, at one point, ever offered a guarantee and refundWe discontinued the money-back guarantee for that procedure in June of The consent form that you signed on November 13th, states the following:
“If I choose the Laser Treatment only, I understand that there is no guarantee or assurance as to the results that may be obtained from this surgical procedure.”
As a result, we are unable to grant your refund requestIf you would like a copy of your signed request, we would be happy to provide that to youWe do sincerely apologize for any inconvenience and we are happy to answer any questions or concernsWe are available during business hours (8-5pm Monday-Friday) at (434) 202-Please note that we are constantly updating our protocols and treatment programs to continue to advance the effectiveness of our treatmentsIf you are still having issues with fungus and ever want to come in for a complimentary follwith *** *** or our new Podiatrist, *** *** *** (perhaps for a different perspective from fresh eyes) to see if there is anything new we can do for you, do not hesitate to call!
*** *** called into the office and emailed stating that she was not happy with this response and “Maybe I need to go to social media and voice my concern with the situation and his practice.” The bottom line is that unfortunately the treatment did not work with ***, as we have found with less than 20% of our patientsHowever, none of those other patients have received a refund nor are they entitled to oneThere is no reason that we can find to grant an exception to *** ***We have not hidden anything from *** *** as far as treatment protocols, plans, and our results, we originally gave her 10% off of the treatment itself, and gave *** an additional laser treatment for free hoping to see some improvementWe have offered multiple times for her to come in and see *** *** and try a prescription topical at no cost to see if we can get some improvementThere is no reason for *** *** to threaten to spread negativity about NovoNail and *** *** on social media. Furthermore, *** *** is including in her refund request a $charge for a shoe sterilizer that she purchased online from a completely separate vendor not associated with NovoNail in the leastShe also included the cost of the cream and topical antifungal from NovoNail, although our company policy is to not allow retail returns or refunds unless the product is originally broken or faulty
We continue to uphold our offer of a free followup for *** with *** *** or *** *** to try some additional options for her nailsIf you need any additional information, do not hesitate to call or email me: ***, *** ***. I was only able to attach documents to this response- if you need additional documents like *** followup forms, please let me know
Thank you for your help in this matter
*** ***
Director of Operations; Certified Laser Technician

I can highly recommend Dr. S[redacted] to anyone,I've been a patient for about 4 years,
and I am extremely happy with the service he has provided, very professional but most important how he treats you like family. His staff is excellent,professional and friendly.I am on my feet 8 working hours a day, I would not trust anyone else with keeping my feet in great shape.

Do not use this company! They charge for their services in advance and refuse to offer any sort of refund. Their receptionist is particularly rude to customers. When I suggested that my mother, who suffers from MS may have made a mistake in purchasing their services, the receptionist told me that she shouldn't be let out of the house by herself. They do not respond to customer complaints in a timely fashion. I had to call many many times before the appropriate manager got back to me. Avoid!

I can highly recommend Dr. S[redacted] to anyone,I've been a patient for about 4 years,
and I am extremely happy with the service he has provided, very professional but most important how he treats you like family. His staff is excellent,professional and friendly.I am on my feet 8 working hours a day, I would not trust anyone else with keeping my feet in great shape.

Review: My daughter, [redacted], has toe nail fungus on 10 toes. I set up a consultation visit with NovoNail to discuss laser treatment. [redacted] is Down Syndrome and I was concerned she would not tolerate the laser treatment. I discussed this in length with [redacted], NovcNail representative, and she was helpful and seemed to be understanding. She told me she believed the treatment would be successful if [redacted] tolerated the laser treatment. [redacted] did great with the laser treatment. No problems at all. I paid for the entire procedure upfront along with creams, oils and products highly recommended by staff of NovoNail. I spent $1,300.00 and her toe nails did not improve at all. On our 3rd visit for laser treatment we met a new technician. [redacted] no longer worked there. We never met [redacted]. Pictures were taken at each visit but he never saw [redacted] in person. By the 4th visit I stated it looked like this treatment was not working. The technician didn't really seem to know what to do or say. I find it hard to believe that a doctor has a patient and the treatment is not working and he never arranges a time to see her in person.Desired Settlement: I expect a full refund of $1,300.00. I was led to believe this treatment would work and it didn't at all. I set up the initial consultation and would have been fine if I had been told they didn't think it would work. However, that is not what happened. They collected all the money upfront and the results were no improvement.

Business

Response:

Regarding the complaint filed by [redacted]:

Here at NovoNail, we strive to provide our patients with the most comprehensive, up to date treatment options available to clear up their toenail fungus. Although we are very confident in our methods and have seen an impressive history of improved results (over 80% effective rate and improving steadily as we continue to research our case load of over 8,000 nails), our methods do not work 100% of the time. With tougher cases like [redacted] nails, we do try to provide different, additional options to try every available avenue before admitting defeat.

With [redacted], we realized we had some limitations in treatment due to her Downs Syndrome. She was not a candidate for surgical nail avulsion or oral medication. During her consultation with our Physician's Assistant, [redacted], [redacted] and [redacted] were told that typically with a case as severe as [redacted], we would recommend nail avulsion- however, this was not an option in this specific instance. According to [redacted] office note from the consultation:

"Chief Review: Thickened, discolored toenails. Has been an ongoing problem for at least 3 years and mother notes it is getting worse. Patient has Down's Syndrome and seizure disorder, mother presents with her, provides history and is planning to be the care provider. States patient does not tolerate pain well and is disinclined to any procedure involving local anesthesia. Notes her PCP directed her to NovoNail after he noticed her toes were getting worse at this year's routine check-up. Mother notes a dermatologist gave them a prescription for ureacin cream and a topical but she has not been faithful and is uncertain if there has been

any improvement. Patient is a poor candidate for PO medications and mother is disinclined to use them. Plan: Condition and various treatment options for toenail fungus were discussed with the patient ranging from oral therapy to surgical avulsion of the nail plate methods. Possible benefits and risks of each

approach were presented. Patient has opted to pursue YAG treatment of affected nails after 2 weeks ureacin pre-treatment for chemical abrasion. Discussed: Use of topicals, Steri-shoe, home care."

We could try breaking down the nails with 2 weeks of a ureacin softening cream, then laser through the nails once they are thinned and softened by the cream. [redacted] decided this is what they would pursue and returned a few weeks later for treatment. The patient and her mother were told before the actual laser treatment that if [redacted] could not tolerate the treatment (tolerate as in handle the pain, noise, etc) and the treatment could not be completed, then of course we would refund her treatment cost. We never told her that we would refund the money if the treatment didn't work, as that is not part of our company policy. We know there is about a 20% chance that a treatment won't work and we let all of our patients know we have about an 80% success rate. We also have each

patient (or in this case, [redacted] mother as guardian) sign a consent form, again stating that the laser treatment is not 100% guaranteed. The consent form is attached. [redacted] also informed the office that [redacted] would prefer to continue seeing [redacted] at subsequent visits because of [redacted] medical history and her overall feeling more comfortable with one person who already knows her case/history instead of seeing a different provider each time. This was the plan carried out until [redacted] had to leave the company, at which time I took over [redacted] care. [redacted] was indeed consulted after every visit and any patient can certainly request any specific provider, whether it is myself, [redacted], or [redacted], with absolutely no issue from the office. If a patient does not request a specific provider, then it is more about rotation and which day they choose to come in for followups that decides who they will see. [redacted], myself, and our receptionist have expressed to [redacted] multiple times that it is not a problem at all if she wants to come in and have [redacted] seen by [redacted] (or our other podiatrist [redacted]).

It is also important to note that [redacted] did not follow our recommended protocols at home. At the consultation, she was told to apply the ureacin cream liberally to all of [redacted] nails every night for 2 weeks before treatment, although when she came in, she stated that she had "used ureacin about 10 times (3-4 nights weekly for the last 4 weeks)" instead (according to [redacted] note). At the initial treatment, she was given paperwork for recommended home care including NovoNail Solution (antifungal topical) twice daily and ureacin cream nightly to thickened nails and calluses, especially for the two weeks prior to next treatment in order to keep the nails thin enough for the laser to work. Clip and file nails as much as possible at home. At the following visit, [redacted] noted that “Mother admits to

NovoNail Solution following last laser treatment but stopped a couple of weeks ago when she resumed the ureacin cream nightly (which was placed on nail,

rubbed in some & then covered with a sock). Taking biotin, has Steri-shoe.” At the second treatment, she was told to use NovoNail Solution twice daily and ureacin cream three times a week, clip and file nails as much as possible. At the third treatment, [redacted] was no longer with NovoNail and I actually saw [redacted] for the third and fourth treatments. At both treatments, [redacted] stated that she was using NovoNail solution about twice a week instead of twice a day and using the cream about 2-3 times a week. At both treatments I suggested using NovoNail solution more often, twice a day recommended but since she had a history of not

remembering to use the topical, try to use it as often as possible. Continue with the ureacin cream to keep nails softened. Clip and file nails as much as

possible at home. At the third treatment, [redacted] nails were showing improvement. I recommended one more treatment to try to clear up the nails even though only three treatments are technically included in the original treatment plan pricing. At the fourth treatment, [redacted] nails had not improved any more for whatever reason, so I listed out some options for [redacted]. I recommended coming back in for an evaluation with either [redacted] or [redacted] to see if we could try a new prescription topical that might give [redacted] that bit of extra strength antifungal action to help continue her improvement we had seen at the last followup (which we would cover financially). We could also try to use the cream for a solid two weeks and relaser after some more aggressive filing and debridement with [redacted].

I sent [redacted] a letter in response to her request for refund stating that her request had been denied:

We at NovoNail recently reviewed your request for a refund. Our records indicate that you underwent a Laser “yag” procedure, and not the full [redacted] treatment (nail removal). The [redacted] is the only procedure for which NovoNail, at one point, ever offered a guarantee and refund. We discontinued the money-back guarantee for that procedure in June of 2012. The consent form that you signed on November 13th, 2013 states the following:

“If I choose the Laser Treatment only, I understand that there is no guarantee or assurance as to the results that may be obtained from this surgical procedure.”

As a result, we are unable to grant your refund request. If you would like a copy of your signed request, we would be happy to provide that to you. We do sincerely apologize for any inconvenience and we are happy to answer any questions or concerns. We are available during normal business hours (8-5pm Monday-Friday) at (434) 202-0744. Please note that we are constantly updating our protocols and treatment programs to continue to advance the effectiveness of our treatments. If you are still having issues with fungus and ever want to come in for a complimentary follow-up with [redacted] or our new Podiatrist, [redacted] (perhaps for a different perspective from fresh eyes) to see if there is anything new we can do for you, do not hesitate to call!

[redacted] called into the office and emailed stating that she was not happy with this response and “Maybe I need to go to social media and voice my concern with the situation and his practice.” The bottom line is that unfortunately the treatment did not work with [redacted], as we have found with less than 20% of our patients. However, none of those other patients have received a refund nor are they entitled to one. There is no reason that we can find to grant an exception to [redacted]. We have not hidden anything from [redacted] as far as treatment protocols, plans, and our results, we originally gave her 10% off of the treatment itself, and gave [redacted] an additional laser treatment for free hoping to see some improvement. We have offered multiple times for her to come in and see [redacted] and try a prescription topical at no cost to see if we can get some improvement. There is no reason for [redacted] to threaten to spread negativity about NovoNail and [redacted] on social media. Furthermore, [redacted] is including in her refund request a $128 charge for a shoe sterilizer that she purchased online from a completely separate vendor not associated with NovoNail in the least. She also included the cost of the cream and topical antifungal from NovoNail, although our company policy is to not allow retail returns or refunds unless the product is originally broken or faulty.

We continue to uphold our offer of a free followup for [redacted] with [redacted] or [redacted] to try some additional options for her nails. If you need any additional information, do not hesitate to call or email me: [redacted], [redacted]. I was only able to attach 4 documents to this response- if you need additional documents like [redacted] followup forms, please let me know.

Thank you for your help in this matter

Director of Operations; Certified Laser Technician