FAQ's

Please, see below the most common questions about of PolyHeal® Micro.

 

General

Most important questions about NCM Technology, indications and safety.

+ More info

Instructions for use

This section includes the most frequently asked questions about the application of PolyHeal® Micro.

+ More info

Clinical evidence

Key highlights of the clinical evidence on NCM Technology.

+ More info

+ 1. What is PolyHeal® Micro?

  • PolyHeal® Micro is an innovative product, based on Negatively Charged Microspheres (NCM) Technology, which is indicated for the treatment of ulcers of different etiologies and hard-to-heal, partial and full-thickness wounds.
  • PolyHeal® Micro works by restarting and accelerating healing through fast production of healthy granulation tissue and rapid re-epithelization rates, result of the stimulation of the key wound bed cells.
  • PolyHeal® Micro is safe and well tolerated.
  • PolyHeal® Micro is a single use, sterile suspension that is easy to apply by physicians, nurses, care takers, patient family or the patients themselves, both in an in-patient or out-patient settings.
  • PolyHeal® Micro is compatible with most traditional wound dressings, however, the recommended primary dressing as a non-woven cotton gauze pad.
  • PolyHeal® Micro provides a cost-effective treatment option for chronic, hard to heal wounds due to the shortened treatment time.
Close

+ 2. What is NCM Technology?

NCM (Negatively charged Microspheres) are synthetic microspheres of medical grade Polystyrene, which are Biocompatible and negatively charged. They have specific surface area and geometry that ensure specific biophysical properties.

Close

+ 3. What is PolyHeal® Micro indicated for?

PolyHeal® Micro is indicated for the treatment of ulcers of different etiologies and hard-to-heal, partial and fullthickness wounds such as:

  • Ulcers with exposed bones, tendons, ligaments and/or foreign material;
  • Venous and arterial leg ulcers, diabetic foot ulcers, pressure ulcers;
  • Drainage, post-traumatic and post-surgical wounds;
  • Hard-to-heal wounds and other ulcers in co-morbid patients.
Close

+ 4. What is the definition of hard to heal, chronic wounds?

  • Chronic wounds are the result of the deregulation of the healing process.
  • The wound will fail to heal in a reasonable time as expected depending on the anatomical site and size.
  • Often healing arrests at the inflammatory phase that will not progress to the proliferative stage.
  • Causes may include wound size, pressure, hypoxia, foreign bodies, dead eschar, infection, several comorbidities or other chronic irritation.
Close

+ 5. Where is PolyHeal® Micro approved?

Currently, PolyHeal® Micro is approved in the EU (27 countries).

Close

+ 6. What is the regulatory status of the device?

PolyHeal® Micro is a Class IIb CE marked medical device.

Close

+ 7. How should PolyHeal® Micro be stored?

PolyHeal® Micro should be stored between 2 C° - 30 C°

Close

+ 8. Are NCM´s safe?

  • All regulatory required pre-clinical safety studies were successfully conducted demonstrating no toxic concern.
  • Overall, NCM´s have been shown to be safe and mostly mild. Unrelated Adverse Events (AEs) were reported in the clinical studies that were resolved by study completion. Only very few related AEs were reported.
  • Generally, AEs associated with NCM´s included redness, swelling, pain (may be relieved by oral analgesics), itching (in the few first days) and skin burning sensation (in the few first days).
Close

+ 9. Do the microspheres remain in the wound? If yes, can this be harmful?

  • Most of the microspheres do not remain in the wound as they are cleared during the dressing process. In vivo animal study results demonstrated that after 3 days following application, about 70% of the NCM’s were eliminated from the wound bed and about 96% were cleared from the wound bed by day 7. The estimated elimination T1/2 is 32 hours from application.
  • There were pre-clinical studies in mice using fluorescent beads that demonstrated that the size of the microspheres was too large to enter the blood or cells and the beads that remain are confined to the wound area. Some of the beads are encapsulated within newly formed tissue in a similar way as tattoo particles. The microspheres are made of medical grade, non-biodegradable polystyrene, are non-toxic and bio-compatible and currently used in medical devices.
  • No gross pathological observations nor pathological histological signs were found during a long term, 28 days, animal safety study.
  • A long term follow up of patients from the RCT was concluded with no special safety concerns.
Close

+ 10. Can PolyHeal® Micro be toxic or even carcinogenic?

Toxicology studies conducted with NCM´s did not reveal toxic or genotoxic findings.

Close

+ 1. After applying PolyHeal® Micro, what should I expect and/or see?

Appearance-wise:

The surface itself may have different appearances according to its condition - clean, exudates, eschar, granulation tissue, etc. As healing progresses, more and more rich, red, granulation tissue, often bleeding with minimal touch, will appear. This tissue is the treatment's expected results. The bleeding is capillary bleeding, from the newly formed fragile new capillaries. With the progression of healing, the granulation tissue may start to change color as it becomes fibrotic, while growing epithelium may further change the color and texture.

Sensation-wise:

In most cases, the sensation is a normal, pain free, similar to routine wet dressing change. Wetting the dressing with water or saline may further ease its removal. In addition, the removed dressing may have some exudates absorbed to its inner surface. In some cases, itching may appear after several days of treatment, which is quite normal in wound healing. If the itching becomes painful and redness appears on the surrounding skin, with or without fever, the patient should consult their treating physician.

Close

+ 2. How will the wounds close following PolyHeal® Micro treatment?

The final goal is to heal and close the wound as soon as possible. Once the wound is covered mostly with healthy granulation tissue, a decision by the treating physician should be taken:

  • If the wound continues to decrease in size, or if the physician foresees that the wound may close spontaneously over an acceptable period of time, PolyHeal® Micro treatment may be continued until total wound closure.
  • The physician could also decide to graft the wound bed over the newly formed granulation tissue to expedite wound closure.
Close

+ 3. When should the physician discontinue the treatment with PolyHeal® Micro to achieve wound closure?

PolyHeal® Micro treatment should be continued as long as there is progress in the creation of a healthy granulating wound bed that enables continuous and complete wound closure or grafting. If the wound discontinues to progress for a medically substantial period of time, the wound may be grafted, when feasible, depending on the condition of the wound bed or alternatively, the physician may change to another treatment modality aimed to facilitate spontaneous wound closure.

Close

+ 4. Are NCM´s safe?

  • All regulatory required pre-clinical safety studies were successfully conducted demonstrating no toxic concern.
  • Overall, NCM´s have been shown to be safe and mostly mild. Unrelated Adverse Events (AEs) were reported in the clinical studies that were resolved by study completion. Only very few related AEs were reported.
  • Generally, AEs associated with NCM´s included redness, swelling, pain (may be relieved by oral analgesics), itching (in the few first days) and skin burning sensation (in the few first days).
Close

+ 5. Do the microspheres remain in the wound? If yes, can this be harmful?

  • Most of the microspheres do not remain in the wound as they are cleared during the dressing process. In vivo animal study results demonstrated that after 3 days following application, about 70% of the NCM’s were eliminated from the wound bed and about 96% were cleared from the wound bed by day 7. The estimated elimination T1/2 is 32 hours from application.
  • There were pre-clinical studies in mice using fluorescent beads that demonstrated that the size of the microspheres was too large to enter the blood or cells and the beads that remain are confined to the wound area. Some of the beads are encapsulated within newly formed tissue in a similar way as tattoo particles. The microspheres are made of medical grade, non-biodegradable polystyrene, are non-toxic and biocompatible and currently used in medical devices.
  • No gross pathological observations nor pathological histological signs were found during a long term, 28 days, animal safety study.
  • A long term follow up of patients from the RCT was concluded with no special safety concerns.
Close

+ 6. What is the preferred dressing to use with PolyHeal® Micro?

It is recommended to use a non-woven cotton Gauze pad or similar, that does not contain active absorptive material other than cotton.

Close

+ 7. Why use gauze to cover PolyHeal® after its application? Isn’t it too primitive?

Gauze was chosen during the clinical study to ensure:

  • There was no adverse interaction between PolyHeal® and the primary dressing.
  • That PolyHeal® is kept in contact with the wound and not absorbed by the primary dressing.
  • To allow for the second daily application, if needed, without disturbing the primary dressing (e.g. the gauze on the wound).

Please be careful while using impregnated dressings and high absorbent dressings as these may interfere with PolyHeal®’s activity.

Close

+ 8. What is the interaction with antibiotics? Silver?

No studies have been conducted to assess PolyHeal® Micro interactions with other agents.

Close

+ 9. Could we cover the gauze with a film?

In the Instructions for use it is recommended to use a conventional bandage to keep the primary dressing in place. If gauze is secured with a film dressing, it should be closely monitored, to diagnose any unsuitable event as soon as it starts. In Venous Ulcers, the compression bandage will be applied over the film dressing, if used.

Close

+ 10. Can you use PolyHeal® Micro with pressure bandages?

Yes. In Venous Ulcers, the compression bandage should be applied over the dressing.

Close

+ 1. In the RCT, why was Polyheal® compared only to Saline dressing?

There is no single, accepted treatment defined as Standard of Care for different wound types, since many treatments answer different needs in different wound etiologies. Saline soaking provides the two most important healing factors: moisture and daily cleansing, thus reducing bacterial and exudates load by dressing change (wet-to-dry) and is used extensively, both in real day life as well as in clinical evaluations. As both PolyHeal® and Saline are clear solutions, using Saline as control enabled to blind the study in accordance with ICH guidelines. These are the reasons that saline dressing is an accepted SOC treatment in comparative, controlled studies.

Close

+ 2. In the RCT, why only 1 month active end point and not until closure?

The primary role of PolyHeal® is to change the status of the wound from stagnant to actively healing. This endpoint has been achieved and measured within 4 weeks of use. Wound closure depends on many additional factors such as the wound size, movement, use of skin grafting or the choice of closure by secondary intention.

Close

+ 3. Were the Saline and Polyheal® groups comparable?

The groups were balanced on most patients ’and wounds’ baseline characteristics, except for wound size and wound duration - wound size was larger in the saline group, whereas wound age was longer in the PolyHeal® group. A post-study regression analysis was performed and confirmed the study results.

Close

+ 4. In the RCT, what happened after the 4 week active phase?

The gaps that had developed between the two treatments arms were maintained during the 8 week follow up period and produced a 2-fold difference in wound closure rate trend.

Close

+ 5. Why did we include multiple wound types in all PolyHeal® studies?

A mixture of wound etiologies reflects the real world variety of hard to heal chronic wounds and demonstrate PolyHeal® efficacy and safety in many different hard to heal wound etiologies.

Close

FAQ's

Please, see below the most common questions about of PolyHeal® Micro.
General

Most important questions about NCM Technology, indications and safety.

+ More info

+ 1. What is PolyHeal® Micro?

  • PolyHeal® Micro is an innovative product, based on Negatively Charged Microspheres (NCM) Technology, which is indicated for the treatment of ulcers of different etiologies and hard-to-heal, partial and full-thickness wounds.
  • PolyHeal® Micro works by restarting and accelerating healing through fast production of healthy granulation tissue and rapid re-epithelization rates, result of the stimulation of the key wound bed cells.
  • PolyHeal® Micro is safe and well tolerated.
  • PolyHeal® Micro is a single use, sterile suspension that is easy to apply by physicians, nurses, care takers, patient family or the patients themselves, both in an in-patient or out-patient settings.
  • PolyHeal® Micro is compatible with most traditional wound dressings, however, the recommended primary dressing as a non-woven cotton gauze pad.
  • PolyHeal® Micro provides a cost-effective treatment option for chronic, hard to heal wounds due to the shortened treatment time.
Close

+ 2. What is NCM Technology?

NCM (Negatively charged Microspheres) are synthetic microspheres of medical grade Polystyrene, which are Biocompatible and negatively charged. They have specific surface area and geometry that ensure specific biophysical properties.

Close

+ 3. What is PolyHeal® Micro indicated for?

PolyHeal® Micro is indicated for the treatment of ulcers of different etiologies and hard-to-heal, partial and fullthickness wounds such as:

  • Ulcers with exposed bones, tendons, ligaments and/or foreign material;
  • Venous and arterial leg ulcers, diabetic foot ulcers, pressure ulcers;
  • Drainage, post-traumatic and post-surgical wounds;
  • Hard-to-heal wounds and other ulcers in co-morbid patients.
Close

+ 4. What is the definition of hard to heal, chronic wounds?

  • Chronic wounds are the result of the deregulation of the healing process.
  • The wound will fail to heal in a reasonable time as expected depending on the anatomical site and size.
  • Often healing arrests at the inflammatory phase that will not progress to the proliferative stage.
  • Causes may include wound size, pressure, hypoxia, foreign bodies, dead eschar, infection, several comorbidities or other chronic irritation.
Close

+ 5. Where is PolyHeal® Micro approved?

Currently, PolyHeal® Micro is approved in the EU (27 countries).

Close

+ 6. What is the regulatory status of the device?

PolyHeal® Micro is a Class IIb CE marked medical device.

Close

+ 7. How should PolyHeal® Micro be stored?

PolyHeal® Micro should be stored between 2 C° - 30 C°

Close

+ 8. Are NCM´s safe?

  • All regulatory required pre-clinical safety studies were successfully conducted demonstrating no toxic concern.
  • Overall, NCM´s have been shown to be safe and mostly mild. Unrelated Adverse Events (AEs) were reported in the clinical studies that were resolved by study completion. Only very few related AEs were reported.
  • Generally, AEs associated with NCM´s included redness, swelling, pain (may be relieved by oral analgesics), itching (in the few first days) and skin burning sensation (in the few first days).
Close

+ 9. Do the microspheres remain in the wound? If yes, can this be harmful?

  • Most of the microspheres do not remain in the wound as they are cleared during the dressing process. In vivo animal study results demonstrated that after 3 days following application, about 70% of the NCM’s were eliminated from the wound bed and about 96% were cleared from the wound bed by day 7. The estimated elimination T1/2 is 32 hours from application.
  • There were pre-clinical studies in mice using fluorescent beads that demonstrated that the size of the microspheres was too large to enter the blood or cells and the beads that remain are confined to the wound area. Some of the beads are encapsulated within newly formed tissue in a similar way as tattoo particles. The microspheres are made of medical grade, non-biodegradable polystyrene, are non-toxic and bio-compatible and currently used in medical devices.
  • No gross pathological observations nor pathological histological signs were found during a long term, 28 days, animal safety study.
  • A long term follow up of patients from the RCT was concluded with no special safety concerns.
Close

+ 10. Can PolyHeal® Micro be toxic or even carcinogenic?

Toxicology studies conducted with NCM´s did not reveal toxic or genotoxic findings.

Close
Instructions for use

This section includes the most frequently asked questions about the application of PolyHeal® Micro.

+ More info

+ 1. After applying PolyHeal® Micro, what should I expect and/or see?

Appearance-wise:

The surface itself may have different appearances according to its condition - clean, exudates, eschar, granulation tissue, etc. As healing progresses, more and more rich, red, granulation tissue, often bleeding with minimal touch, will appear. This tissue is the treatment's expected results. The bleeding is capillary bleeding, from the newly formed fragile new capillaries. With the progression of healing, the granulation tissue may start to change color as it becomes fibrotic, while growing epithelium may further change the color and texture.

Sensation-wise:

In most cases, the sensation is a normal, pain free, similar to routine wet dressing change. Wetting the dressing with water or saline may further ease its removal. In addition, the removed dressing may have some exudates absorbed to its inner surface. In some cases, itching may appear after several days of treatment, which is quite normal in wound healing. If the itching becomes painful and redness appears on the surrounding skin, with or without fever, the patient should consult their treating physician.

Close

+ 2. How will the wounds close following PolyHeal® Micro treatment?

The final goal is to heal and close the wound as soon as possible. Once the wound is covered mostly with healthy granulation tissue, a decision by the treating physician should be taken:

  • If the wound continues to decrease in size, or if the physician foresees that the wound may close spontaneously over an acceptable period of time, PolyHeal® Micro treatment may be continued until total wound closure.
  • The physician could also decide to graft the wound bed over the newly formed granulation tissue to expedite wound closure.
Close

+ 3. When should the physician discontinue the treatment with PolyHeal® Micro to achieve wound closure?

PolyHeal® Micro treatment should be continued as long as there is progress in the creation of a healthy granulating wound bed that enables continuous and complete wound closure or grafting. If the wound discontinues to progress for a medically substantial period of time, the wound may be grafted, when feasible, depending on the condition of the wound bed or alternatively, the physician may change to another treatment modality aimed to facilitate spontaneous wound closure.

Close

+ 4. Are NCM´s safe?

  • All regulatory required pre-clinical safety studies were successfully conducted demonstrating no toxic concern.
  • Overall, NCM´s have been shown to be safe and mostly mild. Unrelated Adverse Events (AEs) were reported in the clinical studies that were resolved by study completion. Only very few related AEs were reported.
  • Generally, AEs associated with NCM´s included redness, swelling, pain (may be relieved by oral analgesics), itching (in the few first days) and skin burning sensation (in the few first days).
Close

+ 5. Do the microspheres remain in the wound? If yes, can this be harmful?

  • Most of the microspheres do not remain in the wound as they are cleared during the dressing process. In vivo animal study results demonstrated that after 3 days following application, about 70% of the NCM’s were eliminated from the wound bed and about 96% were cleared from the wound bed by day 7. The estimated elimination T1/2 is 32 hours from application.
  • There were pre-clinical studies in mice using fluorescent beads that demonstrated that the size of the microspheres was too large to enter the blood or cells and the beads that remain are confined to the wound area. Some of the beads are encapsulated within newly formed tissue in a similar way as tattoo particles. The microspheres are made of medical grade, non-biodegradable polystyrene, are non-toxic and biocompatible and currently used in medical devices.
  • No gross pathological observations nor pathological histological signs were found during a long term, 28 days, animal safety study.
  • A long term follow up of patients from the RCT was concluded with no special safety concerns.
Close

+ 6. What is the preferred dressing to use with PolyHeal® Micro?

It is recommended to use a non-woven cotton Gauze pad or similar, that does not contain active absorptive material other than cotton.

Close

+ 7. Why use gauze to cover PolyHeal® after its application? Isn’t it too primitive?

Gauze was chosen during the clinical study to ensure:

  • There was no adverse interaction between PolyHeal® and the primary dressing.
  • That PolyHeal® is kept in contact with the wound and not absorbed by the primary dressing.
  • To allow for the second daily application, if needed, without disturbing the primary dressing (e.g. the gauze on the wound).

Please be careful while using impregnated dressings and high absorbent dressings as these may interfere with PolyHeal®’s activity.

Close

+ 8. What is the interaction with antibiotics? Silver?

No studies have been conducted to assess PolyHeal® Micro interactions with other agents.

Close

+ 9. Could we cover the gauze with a film?

In the Instructions for use it is recommended to use a conventional bandage to keep the primary dressing in place. If gauze is secured with a film dressing, it should be closely monitored, to diagnose any unsuitable event as soon as it starts. In Venous Ulcers, the compression bandage will be applied over the film dressing, if used.

Close

+ 10. Can you use PolyHeal® Micro with pressure bandages?

Yes. In Venous Ulcers, the compression bandage should be applied over the dressing.

Close
Clinical evidence

Key highlights of the clinical evidence on NCM Technology.

+ More info

+ 1. In the RCT, why was Polyheal® compared only to Saline dressing?

There is no single, accepted treatment defined as Standard of Care for different wound types, since many treatments answer different needs in different wound etiologies. Saline soaking provides the two most important healing factors: moisture and daily cleansing, thus reducing bacterial and exudates load by dressing change (wet-to-dry) and is used extensively, both in real day life as well as in clinical evaluations. As both PolyHeal® and Saline are clear solutions, using Saline as control enabled to blind the study in accordance with ICH guidelines. These are the reasons that saline dressing is an accepted SOC treatment in comparative, controlled studies.

Close

+ 2. In the RCT, why only 1 month active end point and not until closure?

The primary role of PolyHeal® is to change the status of the wound from stagnant to actively healing. This endpoint has been achieved and measured within 4 weeks of use. Wound closure depends on many additional factors such as the wound size, movement, use of skin grafting or the choice of closure by secondary intention.

Close

+ 3. Were the Saline and Polyheal® groups comparable?

The groups were balanced on most patients ’and wounds’ baseline characteristics, except for wound size and wound duration - wound size was larger in the saline group, whereas wound age was longer in the PolyHeal® group. A post-study regression analysis was performed and confirmed the study results.

Close

+ 4. In the RCT, what happened after the 4 week active phase?

The gaps that had developed between the two treatments arms were maintained during the 8 week follow up period and produced a 2-fold difference in wound closure rate trend.

Close

+ 5. Why did we include multiple wound types in all PolyHeal® studies?

A mixture of wound etiologies reflects the real world variety of hard to heal chronic wounds and demonstrate PolyHeal® efficacy and safety in many different hard to heal wound etiologies.

Close